FDA approves the use of first drug developed to treat chronic migraines

The FDA has approved the first drug to prevent migraines

Aimovig (erenumab) has been cleared by the USA regulator as a once-monthly, self-injected preventive treatment for migraines based on data from three clinical trials which showed the drug was able to reduce the number of migraine days in a month compared to placebo.

The drug, Aimovig, belongs to a class called anti-CGRP drugs, short for calcitonin gene-related peptide receptor.

The stock prices of Amgen (amgn) and Novartis (nvs) have popped after the pharmaceutical companies won US approval for a new shot that treats migraines.

"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release.

The wave of new treatments, of which Aimovig is the first to get approval, are going after the huge migraine market. In the second (n=577) and third (n=667) studies, in which patients had a history of chronic migraine, subjects experienced one fewer migraine day and 2-1/2 fewer migraine days, per month on average, respectively.

The FDA has approved the first drug to prevent migraines
FDA Approves Aimovig for Migraine Prevention

Amgen codeveloped Aimovig with Novartis, and are one of four companies pursuing regulatory approval of CGRP inhibitors for the prevention of migraine.

In a statement on Thursday, Express Scripts said migraine patients have a serious unmet need, but "not everyone will need this drug" and it will have a program in place to make sure the medication is authorized for only the appropriate patients.

The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials.

Injection site reactions and constipation were the most common adverse reactions in clinical studies of Aimovig. The companies expect approval in the European Union in the coming months. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine". Although some sufferers respond to safe, easily available painkillers, untreatable migraines represent one of the major causes of disability in the developed world.

As a migraine treatment Botox costs around $3,500 per year, and analysts predict that the annual price for Aimovig will drop to around $5,000 with rebates and discounts.

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