F.D.A. Approves First-of-its-Kind Drug to Prevent Migraines
Suffer from incapacitating migraines? Thursday, May 17, the Food and Drug Administration approved a medicine called Aimovig, which experts believe will help prevent peoples’ severe headaches.
It’s a monthly injection—made by biopharmaceutical company Amgen and global healthcare company Novartis—patients can self-administer (kind of like an insulin pen). The medicine blocks a specific protein fragment—CGRP—that triggers and prolongs migraines, effectively stopping migraines rather than numbing some of their symptoms.
The list price is a hefty $6,900 a year, The New York Times reports, but Amgen says the drug will be available to patients inside of a week.
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“Aimovig provides patients with a novel option for reducing the number of days with migraine,” Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said in a press release. “We need new treatments for this painful and often debilitating condition.”
Aimovig’s efficacy was tested in three separate clinical trials.
In the first study, 955 participants with a history of episodic migraines took Aimovig or a placebo for six months; those on Aimovig experienced one to two fewer monthly migraines, on average, than those on the placebo. The second study, including 577 patients, also found Aimovig to be effective in reducing the number of episodic migraines; this time it was over the course of three months and people, on average, had one fewer migraine day per month. The third study looked at 667 patients with a history of chronic migraines. Patients who were on Aimovig for three months had about two and a half fewer migraine days per month.
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Common side effects were mild: Some patients exhibited reactions at their injection site, and constipation.
Aimovig can revolutionize the way we treat migraines. And while it’s not a panacea, it’s a huge leap forward for those who suffer from monthly migraines.
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