The FDA has approved the first drug to prevent migraines

The FDA has approved the first drug to prevent migraines

The U.S. Food and Drug Administration (FDA) approved on Thursday a new drug 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.

USA regulators Thursday approved the first drug created to prevent chronic migraines.

"Having a treatment created to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine", said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School in New Hampshire, in a statement. These are most common among people who are in their 30s, especially the women, and can stay for long hours or in worst cases, even days.

The wave of new treatments, of which Aimovig is the first to get approval, are going after the huge migraine market.

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FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention [press release]. 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.

Amgen Inc is also in collaboration with the Swiss pharmaceutical firm Novartis that can help in commercializing the medication rapidly and across the globe.

Results show that patients taking the drug had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).

The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month). CGRP has been known to play a significant role in migraines since the 1980s and 1990s, though it's taken some time to develop the technology that can leverage it. If approved, the drugs are expected to cost US$8,500 per year. The most commonly reported adverse events through all trials have been injection site reactions and constipation.

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