#anti cgrp monoclonal antibodies

[chronicmigrainetime]

One year on Ajovy update!:

I can’t believe it’s been a year already, it’s gone so fast. I stopped doing monthly updates because the situation hasn’t really changed since the effect of the medication stabilised. I currently get ~10/30 migraine days a month —down from 30/30 before the medication— and my quality of life has improved dramatically as a result.

(Finding medication to help my POTS has also had a huge positive impact)

I’m still not really able to work a job, but I have been able to do a lot more of the work of being a person.

I had a review with the headache clinic that’s prescribing the Ajovy for me and they decided I can continue on it for another year (with another review at the end of the year), which is really good news.

[scientia-rex]

Hello, I appreciate your medical posts very much and having seen a post the other day where you said migraine was in your areas of special interest, I'd love to ask a related question. You talk about bodies and medicine and patient experience etc in a way that makes a lot of sense to me and I'd trust your take.

I have chronic migraine. I'm currently at 100% pain days, with varying severity. Very hard to pin down what is prodrome, the main event, and postdrome as it's all blurred into one. My migraine team want me to reduce painkiller usage (currently dihydrocodeine and paracetamol daily, and ibuprofen maybe every other day on top) due to rebound headache. I want to cut down because they're fucking expensive and I'm scared for my liver and kidneys. But I literally can't cope with life without them. I went off them for four months a few years ago and the pain was so severe and so debilitating I was the most suicidal I've been in my life. Without painkillers I can't get to the toilet unaided, rarely leave bed, even more rare to leave the house. It's hell. And that's not even considering the effects on everyone around me who has to pick up to care for me.

So what do I do? The way I see things, I need something to help the pain improve before I can use less painkillers, but the longer I go on trying to find something that works and not getting there, the more I think maybe I'm wrong in that. I know a bit about how codeine based painkillers can reduce your pain tolerance / pain baseline. I don't think it's an addiction issue because I've been at the same (over the counter) dosages for 4 years now. I just want to do all that I can to be better, but I also need to be alive to be better. I am stuck.

TL;DR - If you have any thoughts on the relationship between chronic migraine, painkiller use, preserving quality of life while finding a treatment, and increasing the chances of a treatment working, and where on earth the balance between all that lies, I'd really like to hear them.

Again, I absolutely appreciate if you can't answer this, don't want to etc. Giving advice online is notoriously tricky and all that. But a big thank you for your time in reading, and all your weight and exercise posts especially which make me feel so much better about my body. Wishing you all good things! 💖

I won't speak to your case directly, since I'm not your doctor, but here is my personal algorithm for escalating treatments for migraine (note that "abortives" in this case means something you take after a migraine starts to try to end it, while "prophylactic" means a daily treatment you take to reduce likelihood of developing a migraine):

-OTC combination of magnesium, feverfew, and butterbur, taken daily

-Triptans (insurance will usually demand patients fail at least 3 to cover a more expensive treatment)

-High-dose NSAIDs (as abortive treatment given risk of rebound headaches if used daily)

-Daily topiramate (insurance will always demand this is either failed or there's a clear contraindication)

-Daily calcium channel blockers

-Daily beta blockers (higher dose than used for anxiety or low-grade arrhythmias)

-Daily anti-epileptic medications (such as Lamictal)

-Monthly anti-CGRP monoclonal antibody injections (Aimovig or Ajovy; expensive so insurance will demand you've failed some or all of the previous meds)

-Abortive anti-CGRP orals (Nurtec or Ubrelvy)

-Abortive ergotamine, usually Migranal, a nasal spray (very expensive and must be repeated 15 minutes after initial dose regardless of whether symptoms are improving or not)

-Prophylactic Botox (I believe this is every 3 months, must be done in the office of a trained and licensed professional, usually but not always a Neurology provider)

-Sphenopalatine ganglion blocks (done by dripping lidocaine far back into the sinuses to reach the sphenopalatine ganglion, again in the office of a trained and licensed professional)

-Cephaly (transcranial magnetic stimulation at-home device), expensive so insurance hates covering it

Now, one of my newer tools, and my current personal favorite, is a greater occipital nerve block--easy and fast, low risk, and I've had about 90% success with my patients in aborting current headaches. Effects seem to last 3-4 weeks in most cases and since it's straight lidocaine (you don't have to include steroids, though you can) you can do it as often as needed. I generally do this in my office, but I did train one patient's spouse to do it at home given how frequent their headaches. The pharmacy lost their fucking mind about letting an outpatient have lidocaine. I don't know why.

I currently manage my pretty awful chronic migraines with a combination of monthly Aimovig, as-needed Excedrin (the combination of caffeine, Tylenol aka paracetamol, and aspirin is effective for many people but is a real risk for causing medication overuse headaches, the more official term for bounce-back), as-needed Ubrelvy (I can sleep after taking Ubrelvy but not Excedrin so it's a good option), and roughly monthly greater occipital nerve blocks (I teach my trainees to do it using myself as a subject). I wouldn't mind trying the Botox but it's a PITA to get in to see our only local Neurology provider and since my migraines are relatively well-controlled (probably 1-2 headache days a week right now) I don't think it's worth the effort.

I also really got a lot out of this lecture, so give it a try.

[poesielibre]

Medical/ prescription medication rant

So I've caught a cold following visit family out town. The thing is I got really bad brain fog for days. I am now looking at scientific articles and studies of the effect of anti-cgrp monoclonal antibodies (that is part of my migraine treatment) on the immune system. The reading is eye opening. Since this is and actual new class of medication the long term side effects are unknown.

Reading these articles makes me feel like people who are prescribed those medication are just test subjects. Except the risks are real. But when this type of medication is prescribed it is a last resort, it is prescribed because nothing else works. And yet we are told there are barely any side effects. I took another version two years ago and stopped because the side effects were becoming too much to handle and my immune system was actually better than now.

[mcatmemoranda]

I have a pt with chronic migraines whom I referred to neurology. They mentioned "CGRP mabs" for treatment option. So I looked it up:

Anti-CGRP monoclonal antibodies (mAb) are an innovative therapeutic class that fulfills the need for more efficacious and tolerable preventive therapy. While erenumab is a mAb to the CGRP receptor, eptinezumab, fremanezumab, and galcanezumab bind to the CGRP molecule.

[bhaashpathak]

Migraines - Neural Causes and Prevention Strategies

Migraines affect millions of people around the world. Unlike headaches, migraines are characterized by severe episodic pain that typically targets one side of the head. Ongoing research aims to unravel the causes of migraines in hopes of developing effective treatment and prevention strategies.

One of the well-researched focal points related to migraines is the trigeminal nerve. Also known as the fifth cranial nerve, the trigeminal nerve carries sensory signals, including pain signals, to the brain. To successfully carry these signals, the nerve has specific receptors called transient receptor potential channels, or TRPs. TRPs identify stimuli and translate them into electrical signals. The trigeminal nerve then sends these signals to the brain. Research focusing on TRPs has shown that modifying their activity can be key in treating migraines.

For example, Botulinum toxin is a specific chemical that interferes with TRPs. More commonly known as Botox, the chemical is used for cosmetic purposes, but recent research demonstrates its beneficial effects for migraine management. Administrated as forehead injections, Botox sessions have proven successful in reducing the frequency of migraines. In 2010, the Food and Drug Administration (FDA) approved Botox for the therapeutic management of chronic migraine.

Another chemical target for migraine therapy is calcitonin gene-related peptide (CGRP). CGRP activates nerves that sense pain, which later communicate and stimulate the trigeminal nerve. The trigeminal nerve itself also releases CGRP. Research findings illustrate that inhibiting CGRP activity using anti0CGRP monoclonal antibodies can prevent migraines. However, these CGRP inhibitors may result in side effects such as high blood pressure and constipation.

The trigeminal nerve also controls eight facial muscles, most of which are in charge of mastication movements such as biting and chewing. It may be overstimulated and, as a result, triggers dilation of the blood vessels in the brain, leading to migraines and other types of headaches. Migraines caused by the trigeminal nerve can manifest in various ways. In addition to unilateral throbbing headaches, they may also be associated with nausea, vomiting, and increased sensitivity to sensory stimuli, including light and sound. The overstimulation of the trigeminal nerve can be due to jaw-related disorders like temporomandibular joint (TMJ) syndrome. In TMJ cases, painful jaw movements can overstimulate the trigeminal nerve and cause migraines.

Common methods to prevent migraines are largely drug-based. A wide range of medications that treat high blood pressure, seizures, and depression can prevent migraines. Beta-blockers like propranolol mainly reduce blood pressure but are also useful in migraine prevention. Some people use topiramate as an anti-seizure medication to prevent migraines. Two different types of antidepressants – tricyclic antidepressants and selective serotonin reuptake inhibitors – can also be helpful.

External stimuli can also trigger migraines. People experiencing high levels of stress often struggle with frequent migraines. Certain foods, weather changes, and poor sleep are linked to migraines. Therefore, people can rely on non-pharmaceutical methods of managing stress and regulating their sleep or diet to limit migraines. Certain vitamin and mineral supplements, including vitamin B2 and magnesium, could help prevent migraines without causing significant side effects.

[mednerds]

A visual guide to migraine headaches

The pain, the pressure, the way it ruins your mood — everyone has experienced a headache at one time or another. But whereas most are transient and easily managed, migraines are stubborn and debilitating.

Blueprint of a migraine

A migraine attack comprises several phases, of which the headache is just one: other symptoms, such as fatigue and muscle stiffness, can precede the headache by several days and linger after it has passed. Some people also experience neurological disturbances known as aura. The mechanisms behind pain and aura are not certain, but theories abound.

A painful pathway

The headache phase can last between 4 and 72 hours. It is characterized by pulsing or throbbing pain on one or both sides of the head, nausea and vomiting, and sensitivity to light, sound, smell and touch. The leading theory of migraine is that headache is the result of activation of the trigeminovascular system, the network of nerves linked to blood vessels in the head.

Strange sensations

Symptoms include seeing lights or shapes, vision loss and prickling sensations in an arm or leg. They develop over 15–20 minutes and last less than an hour.

It is widely thought that auras are caused by a slow-moving wave of depolarization that passes through the brain, known as cortical spreading depression (CSD).

Pharmaceutical options

Drugs are not the only choice for treating migraine, but there are numerous options available, including over-the-counter non-steroidal anti-inflammatory drugs, opioids and monoclonal antibodies. They work by various mechanisms, not all of which are completely understood, to interrupt the pain.

Triptans

Tryptamine-based drugs were introduced in the 1990s. They mimic the activity of the neurotransmitter serotonin (5-HT) and are effective in the early stages of an attack. At 5-HT1B receptors, they reduce pain by causing cranial blood vessels to constrict. At 5-HT1D receptors, they block the release of neuropeptides that trigger inflammation.

Monoclonal antibodies

Monoclonal antibodies against CGRP, first approved in 2019, are given by injection to prevent migraine attacks. The antibodies bind to either CGRP or its receptor to stop the peptide from dilating blood vessels and increasing inflammation in the meninges. They also block the transmission of pain along the trigeminal pathway.

Botox

Onabotulinumtoxin A, or Botox, is a neurotoxin that was approved for use in chronic migraine in the United States in 2010. It is given by injection and can prevent attacks for up to 90 days. Botox interferes with the neurotransmitter acetylcholine (ACh) by breaking a protein required for its release at a synapse. This prevents ACh from activating pain-receptor fibres in the brain.

Migraine and its cousins

Migraine is a major category of headache, but it is not the only type. Tension headaches are more common, yet generally less painful, whereas cluster headaches are excruciatingly painful but fortunately rare.

Source: By Neil Savage, Nature 586, S2-S3 (2020) doi: https://doi.org/10.1038/d41586-020-02861-w

[udaycmi]

According to a new study published by Polaris Market Research the worldwide monoclonal antibodies market is anticipated to reach over USD 148.9 billion by 2026. In 2017, by indication, the cancer segment dominated the global market in terms of revenue; wherein fully-human monoclonal antibodies held a major share of the market. In terms of geography, North America accounted for the majority share in the global monoclonal antibodies market.

The monoclonal antibodies (mAbs) market is mainly driven by an active pipeline, wherein many monoclonal antibodies are at the different stages of drug development. In addition, increased in research and development, favorable government policies and rising prevalence of cancer and other chronic diseases supplement the market growth. The other factors that augment that market growth include the increasing the demand for personalized medicine and rising awareness among medical professional and patients about the latest medical therapies. Moreover, emerging targets such as central nervous system disorders, price correction and new delivery strategies for monoclonal antibodies provide opportunities for market growth in the near future.

Get Sample copy of this report: https://www.polarismarketresearch.com/industry-analysis/global-monoclonal-antibodies-mabs-market/request-for-sample

Monoclonal antibodies constitute a major share of the pharmaceutical market with several monoclonal antibodies still in the pipeline. With over 30 monoclonal antibodies approved for use by regulatory authorities, many monoclonal antibodies are in the pipeline at the pre-clinical stage and various stages of clinical trials. Furthermore, availability of advanced technology for monoclonal antibodies production has egged on many other market players to develop their own pipelines. Also, in the last few years the patents of many monoclonal antibodies have expired thereby encouraging other pharmaceutical companies to undertake production of monoclonal antibodies.

Personalized medicine is being redefined by monoclonal antibodies that are the cutting-edge form of immunotherapy. The surge in the demand for personalized medicine plays a crucial role in boosting the monoclonal antibodies market by giving an impetus to the development of personalized drug targets as every patient responds differently to different treatment regimens. Moreover, other factors such as specificity, homogeneity and relatively fewer adverse events that entail usage of personalized medicine contribute to significant market growth.

The leading companies operating in this industry include Pfizer, Inc., GlaxoSmithKline PLC, Novartis AG, Merck & Co., Inc., Eli Lily & Co., AstraZeneca, Amgen, Inc., Abbott Laboratories, Thermo Fisher Scientific, Inc., Bistro-Myers Squibb. Mylan N.V., Daiichi Sankyo Company, Ltd., Bayer AG, Hoffmann-La Roche Ltd., and Novo Nordisk A/S. The market players have adopted various strategies such as novel product development, new product release, and venture capital investments among others to establish a foothold in the market and increase their customer base.

Request For Discount: https://www.polarismarketresearch.com/industry-analysis/global-monoclonal-antibodies-mabs-market/request-for-discount-pricing

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[chronicmigrainetime]

A tip for anyone taking Ajovy via auto-injector pen (and probably relevant for other auto-injector medications that have to be refrigerated and then brought to room temperature before injecting):

Once the pen has had a few hours out of the fridge to warm up a bit, hold it against your skin for a couple of minutes before you use it. This’ll make sure the pen is closer to the temperature (of the outside) of your body and it’ll be less of a shock introducing cold liquid into your warm body

I find this makes doing the injections hurt a lot less, especially if the ‘room temperature’ in my room is lower than room temperature is supposed to be

(Note: do not use any active method to warm up your medication as this could denature the medication! For comfortable injection it only needs to be as warm as the surroundings, hence using the surroundings to warm it)

[scientia-rex]

Man, I haven’t been sure why my mood has been crap lately—I figured it was because of the lawsuit—but it did just occur to me that I’ve been off my Aimovig for about as long as I’ve been feeling really crappy. I just haven’t had time to make an appointment with my neurologist to get it refilled and her wait list is like 6 months and I hate stabbing myself anyway. But what if an anti-CGRP monoclonal antibody decreasing inflammation actually improves my mood?????? I need to do some reading. Any migraine researchers got any thoughts about this?

[shayanvatandoost-blog]

. ♨️ میگرن یک بیماری رایج در میان جوامع امروزی است. این بیماری فقط شامل سردرد نیست و علائم دیگری در سراسر بدن دارد. تا قبل از سال ۲۰۱۹ دارویی مختص میگرن تأیید نشده بود و از دسته داروهای دیگری مانند NSAID ها برای کاهش درد و داروهای ضد تهوع مانند سوماتریپتان استفاده میشد. این داروها فقط بیماری را کنترل میکردند و در بسیاری موارد کارایی لازم را نداشتند اما در دو سال اخیر دسته ی داروی جدیدی با عنوان آنتاگونیست های calcitonine gene-related peptide به بازار معرفی شدند و اثرات خوبی مخصوصا بر روی افراد با سردرد های شدید میگرنی از خود نشان دادند. تا به امروز سه مونوکلونال آنتی بادی Eptinezumab و Fremanezumab و Galcanezumab از این دسته دارویی برای میگرن توسط FDA تأیید شده اند و مصرف آنها به صورت تزریق ماهانه است. در دسامبر ۲۰۱۹ داروی Ubrogepant نیز برای درمان میگرن توسط FDA تأیید شد. . . . 🌐 Migraine is a common disease in today's society. The disease does not only include headaches and includs other symptoms throughout the body too. Prior to 2019, migraine medications were not approved, and other medications, such as NSAIDs, were used to reduce pain and anti-nausea medications such as sumatriptan. These drugs only controlled the disease and in many cases were not effective, but in the last two years a new class of drugs called calcitonine gene-related peptide antagonists have been introduced to the market and have good effects, especially on people with severe migraine headaches. They showed themselves. To date, three monoclonal antibodies Eptinezumab, Fremanezumab, and Galcanezumab have been approved by the FDA for migraine and are given monthly as injections. In December 2019, Ubrogepant was approved by the FDA for migraine treatment. . . . 📚منبع: https://www.health.harvard.edu/blog/cgrp-new-era-migraine-treatment-2018030513315 . . (at Tehran, Iran) https://www.instagram.com/p/B_z34PiJQBA/?igshid=bahi2776fsep

[neurogenpapers]

Induction of Migraine-Like Photophobic Behavior in Mice by Both Peripheral and Central CGRP Mechanisms.

PubMed: Related Articles Induction of Migraine-Like Photophobic Behavior in Mice by Both Peripheral and Central CGRP Mechanisms. J Neurosci. 2017 Jan 04;37(1):204-216 Authors: Mason BN, Kaiser EA, Kuburas A, Loomis MM, Latham JA, Garcia-Martinez LF, Russo AF Abstract The neuropeptide calcitonin gene-related peptide (CGRP) is a key player in migraine. Although migraine can be treated using CGRP antagonists that act peripherally, the relevant sites of CGRP action remain unknown. To address the role of CGRP both within and outside the CNS, we used CGRP-induced light-aversive behavior in mice as a measure of migraine-associated photophobia. Peripheral (intraperitoneal) injection of CGRP resulted in light-aversive behavior in wild-type CD1 mice similar to aversion seen previously after central (intracerebroventricular) injection. The phenotype was also observed in C57BL/6J mice, although to a lesser degree and with more variability. After intraperitoneal CGRP, motility was decreased in the dark only, similar to motility changes after intracerebroventricular CGRP. In addition, as with intracerebroventricular CGRP, there was no general increase in anxiety as measured in an open-field assay after intraperitoneal CGRP. Importantly, two clinically effective migraine drugs, the 5-HT1B/D agonist sumatriptan and a CGRP-blocking monoclonal antibody, attenuated the peripheral CGRP-induced light aversion and motility behaviors. To begin to address the mechanism of peripheral CGRP action, we used transgenic CGRP-sensitized mice that have elevated levels of the CGRP receptor hRAMP1 subunit in nervous tissue (nestin/hRAMP1). Surprisingly, sensitivity to low light was not seen after intraperitoneal CGRP injection, but was seen after intracerebroventricular CGRP injection. These results suggest that CGRP can act in both the periphery and the brain by distinct mechanisms and that CGRP actions may be transmitted to the CNS via indirect sensitization of peripheral nerves. SIGNIFICANCE STATEMENT: The neuropeptide calcitonin gene-related peptide (CGRP) is a central player in migraine pathogenesis, yet its site(s) of action remains unknown. Some preclinical studies have pointed to central sites in the brain and brainstem. However, a peripheral site of action is indicated by the ability of intravenous CGRP to trigger migraine in humans and the efficacy of CGRP receptor antagonists that evidently do no penetrate the CNS in effective amounts. Resolving this issue is particularly important given recent clinical trials showing that anti-CGRP monoclonal antibodies can reduce and even prevent migraine attacks. In this study, we report that CGRP can act in both the brain and the periphery of the mouse to cause migraine-like photophobia by apparently distinct mechanisms. PMID: 28053042 [PubMed - in process] http://dlvr.it/N3CDDK

[pharmamktnet]

Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults

Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the European Commission (EC) has granted the Marketing Authorization for AJOVY (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY is a humanized monoclonal antibody (mAb) that binds…

[dani-qrt]

Novartis readies anti-sexism message for migraine drug

ZURICH (Reuters) – With women hardest hit by migraine headaches, Swiss drugmaker Novartis is gearing up its marketing message to counteract sexism that it worries might become a barrier to adoption of its new medicine Aimovig. 

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

The injectable monoclonal antibody that Novartis has developed with Amgen won approval in the United States this month and on Friday bagged a recommendation from a key European panel, clearing the way for likely approval on the continent.

The drug is expected to be high priced, though countries negotiate their own terms with the company. In the United States, the drug is priced at $6,900 a year. Novartis is also considering new pricing models for Aimovig.

Novartis’s top neuroscience developer Dan Bar-Zohar said he is keenly aware that most migraine sufferers are women. The Basel-based company has data to combat scepticism about the severity of migraines in women.

“We are tailoring quite a lot of our messages to this relevant population. We are extremely aware of this gender bias,” Bar-Zohar said in an interview with Reuters.

“We have science-based evidence to show this is not just a headache.”

To reflect the community of migraine suffers, Novartis said that about 85 percent of those who took part in its clinical trials were women.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the drug for treating migraine headaches in adults. The European Commission’s backing usually follows in just a couple of months.

The medicine, also called erenumab or AMG334, is the first in a new class of treatments designed to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain.

In the United States, Amgen and Novartis are pricing the self-injection drug at $575 a month, before discounts.

There, prescription benefits managers had taken aim at the drug, announcing in advance that they saw it as a test case to help rein in prices.

Bar-Zohar did not give details on potential pricing in Europe, where cost can differ widely from country to country. But he did say that Novartis is considering a variety of models — including an approach in which it would quickly identify patients who respond to the treatment — to help determine reimbursement levels.

“We are exploring some innovative methods in order to price it right,” he said, adding Novartis wants to avoid the traditional “pay, fire and forget” model where it is reimbursed by the pill, in favor of an approach that delivers more value to health care systems and patients.

Studies of the Amgen-Novartis drug included patients who were new to migraine treatments, as well as patients who had tried other therapies unsuccessfully before abandoning them.

A late-stage trial of Aimovig found that it reduced episodic migraines by at least half in 30 percent of patients who had failed up to four previous treatments.

“These people live literally in the dark,” Bar-Zohar said. “This is a breakthrough.”

Though Aimovig has a head start, competition from makers of would-be rival medicines could eventually become fierce.

Companies including Teva Pharmaceutical Industries <TEVA.TA,>, Eli Lilly & Co and Alder Biopharmaceuticals Inc are developing similar treatments.

Analysts, on average, have forecast annual Aimovig sales of nearly $1 billion by 2022, according to Thomson Reuters I/B/E/S, with Novartis sharing a smaller piece of the proceeds.

Novartis and Amgen are selling Aimovig in the United States. Amgen has commercialization rights in Japan, while Novartis has the rights elsewhere.

Reporting by John Miller in Zurich and Justin George Varghese in Bengaluru; Editing by Edmund Blair and Adrian Croft

The post Novartis readies anti-sexism message for migraine drug appeared first on World The News.

from World The News https://ift.tt/2J7Uuqi via Online News

[chronicmigrainetime]

Four months on ajovy update:

I completely forgot to do a three month update because I’ve been very busy but things have pretty much continued to be the same as the two month update.

The 3 month review went great, they said that I had a 70% reduction in migraines (30 days -> 9 days), which was more than enough for me to stay on the ajovy. Now I will have another review once I have been on it for a year. I don’t know what will happen at this review. I’ve seen some things saying that if the migraines days are below a certain threshold you trial coming off the medication, but I don’t know what the threshold is or what happens if you’re not below it. This drug is also pretty new on the NHS so it’s possible that the guidelines will have changed by the time I get there as they get more data.

In the last two months I have continued to have about 9 migraine days a month. These migraine days almost exclusively occur in the week before my injection and the week after it, so I’m assuming this is due to the medication slowly wearing off before the injection and then taking a little time to ramp back up after the injection. This means I’m essentially in a pattern of two good weeks and then two bad weeks, which is an interesting place to be. I’m so incredibly glad to have the two good weeks, it’s really wonderful, and even the bad weeks are better than they were before this medication, but I still can’t commit myself to anything that is weekly (or, god forbid, daily) because I know I won’t be up to it for half of the weeks. Essentially, I’m much more able to exist now, but I’m not quite able to be fully part of the world again yet. That said it is very nice to have some level of regularity to when I feel worse, that way I can plan around it and cut myself more slack when it’s happening.

The injection pens themselves are now being delivered to me in boxes of 3 every 3 months, I use 1 pen a month and keep the rest in the fridge.

Unfortunately, doing the injections seems to have gotten worse over time. I’ve done 5 now, and I think the knowing what it’s going to be like makes it harder to do. It is very difficult to knowingly stab yourself. For me I’ve found that injecting into the stomach is manageable but injecting into the leg is excruciatingly painful, it also seems to be worse if either me or the medication is too cold so it might just be worse during the winter in general.

I’ve continued to have no side effects other than injection site reactions. The level of reaction at the injection site seems to vary a lot and I don’t really know why. Sometimes it’s basically non-existent, sometimes (like this time) it’s bruised and painful for several days. While this is irritating, it is absolutely amazing that there are no other side effects of this medication. This is such a massive step up from the other medications I’ve tried.

[dragnews]

Novartis readies anti-sexism message for migraine drug

ZURICH (Reuters) – With women hardest hit by migraine headaches, Swiss drugmaker Novartis is gearing up its marketing message to counteract sexism that it worries might become a barrier to adoption of its new medicine Aimovig. 

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

The injectable monoclonal antibody that Novartis has developed with Amgen won approval in the United States this month and on Friday bagged a recommendation from a key European panel, clearing the way for likely approval on the continent.

The drug is expected to be high priced, though countries negotiate their own terms with the company. In the United States, the drug is priced at $6,900 a year. Novartis is also considering new pricing models for Aimovig.

Novartis’s top neuroscience developer Dan Bar-Zohar said he is keenly aware that most migraine sufferers are women. The Basel-based company has data to combat scepticism about the severity of migraines in women.

“We are tailoring quite a lot of our messages to this relevant population. We are extremely aware of this gender bias,” Bar-Zohar said in an interview with Reuters.

“We have science-based evidence to show this is not just a headache.”

To reflect the community of migraine suffers, Novartis said that about 85 percent of those who took part in its clinical trials were women.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the drug for treating migraine headaches in adults. The European Commission’s backing usually follows in just a couple of months.

The medicine, also called erenumab or AMG334, is the first in a new class of treatments designed to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain.

In the United States, Amgen and Novartis are pricing the self-injection drug at $575 a month, before discounts.

There, prescription benefits managers had taken aim at the drug, announcing in advance that they saw it as a test case to help rein in prices.

Bar-Zohar did not give details on potential pricing in Europe, where cost can differ widely from country to country. But he did say that Novartis is considering a variety of models — including an approach in which it would quickly identify patients who respond to the treatment — to help determine reimbursement levels.

“We are exploring some innovative methods in order to price it right,” he said, adding Novartis wants to avoid the traditional “pay, fire and forget” model where it is reimbursed by the pill, in favor of an approach that delivers more value to health care systems and patients.

Studies of the Amgen-Novartis drug included patients who were new to migraine treatments, as well as patients who had tried other therapies unsuccessfully before abandoning them.

A late-stage trial of Aimovig found that it reduced episodic migraines by at least half in 30 percent of patients who had failed up to four previous treatments.

“These people live literally in the dark,” Bar-Zohar said. “This is a breakthrough.”

Though Aimovig has a head start, competition from makers of would-be rival medicines could eventually become fierce.

Companies including Teva Pharmaceutical Industries <TEVA.TA,>, Eli Lilly & Co and Alder Biopharmaceuticals Inc are developing similar treatments.

Analysts, on average, have forecast annual Aimovig sales of nearly $1 billion by 2022, according to Thomson Reuters I/B/E/S, with Novartis sharing a smaller piece of the proceeds.

Novartis and Amgen are selling Aimovig in the United States. Amgen has commercialization rights in Japan, while Novartis has the rights elsewhere.

Reporting by John Miller in Zurich and Justin George Varghese in Bengaluru; Editing by Edmund Blair and Adrian Croft

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