FDA/CDC

FDA approves Aimovig for migraine prevention


 

The Food and Drug Administration has approved Aimovig (erenumab-aooe), delivered once a month via injection, for the prevention of migraines in adults.

Aimovig is the first FDA-approved treatment developed to prevent migraines by blocking the calcitonin gene–related peptide receptor.

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Approval for the drug was based on results from three clinical trials. In the first, which included 955 patients with episodic migraine, patients treated with Aimovig over a 6-month period had, on average, 1-2 fewer migraine days per month than those who received placebo. In the second, which included 577 patients with episodic migraine, those treated with Aimovig over a 3-month period had, on average, 1 fewer migraine day per month versus those who received placebo.

The final clinical trial included 667 chronic migraine patients, and over a 3-month period, those treated with Aimovig had, on average, 2.5 fewer migraine days per month, compared with those who received placebo.

The most commonly reported adverse events were injection-site reactions and constipation.

“Aimovig provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition,” Eric Bastings, MD, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the press release.

Find the full press release on the FDA website.

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