FDA Approves New Drug for Prevention of Migraine

Erenumab (Aimovig) first-in-class for adult patients

Last week, the U.S. Food and Drug Administration approved the fully human monoclonal antibody erenumab (Aimovig) for the prevention of migraine in adult patients.

The once-monthly, self-injectable drug, a product of Amgen and Novartis, is the first in its class to receive FDA approval for this indication.

“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,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA indicated recent strong performances in clinical trials persuaded them to issue approval for the drug.

Findings from one such trial were presented at the American Academy of Neurology (AAN) 2018 annual meeting in April. The study, which included 246 patients with refractory episodic migraine, showed that a 50 percent or greater reduction in mean monthly migraine days (MMDs) was achieved by 30 percent of people treated subcutaneously once monthly with erenumab vs. 13.7 percent of those receiving matching placebo.

It won’t take long for patients for reap the benefits, as the drug is expected to be available almost immediately.

SOURCE: Medscape

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