"Aimovig provides patients with a novel option for reducing the number of days with migraine", said Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Amgen Inc announced Thursday the US Food & Drug Administration has approved Aimovig or erenumab-aooe for the preventive treatment of migraine in adults. "Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine", Novartis Chief Executive Paul Hudson said in the statement. There is a need to add more treatment plans for this painful and often debilitating condition. In a dedicated study with patients with difficult-to-treat conditions - like those with episodic migraine who have failed two to four prior treatments - a dose of Aimovig 140 mg resulted in an nearly tripling of the chance of reducing their migraine days by half compared to a placebo. 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.
In fact, 85 percent of migraine patients stop taking drugs for the disorder within a year.
Amgen and Novartis have beaten Lilly's galcanezumab, Teva's fremanezumab and Alder's eptinezumab to market, with first-mover advantage in a market for CGRP drugs that is expected to grow from zero to $4bn or more by 2026.
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The drug is called Aimovig and is made by pharmaceutical giants Amgen and Novartis.
The most common side effects reported by patients in the trials were injection site reactions and constipation. The companies expect approval in the European Union in the coming months.
The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. Lilly and Teva weren't yet active. In all instances, participants administered with Aimovig suffered significantly fewer episodes than those on placebos.
The effects on monthly migraine days were shown to be continued for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days a month). While out-of-pocket costs will vary based on patient insurance status, Amgen and Novartis have launched the Aimovig Ally program and Aimovig Copay Program to help reduce costs to as low as $5 per month for commercially-insured patients and help uninsured patients identify potential access resources.