USA approves 1st drug developed to prevent chronic migraines

Cornelia Mascio
Mag 18, 2018

The US Food and Drug Administration approval for the first drug to prevent migraine headaches in adults has been won by Amgen Inc.

Erenumab will cost $575 for a once-monthly dose of 70 mg or 140 mg, or $6900 annually. Any discounts or rebates will depend on negotiations with health plans, Amgen spokeswoman Kristen Davis said.

The price as expected by some Wall Street experts was going to be Dollars 10,000 a year.

The drug has been evaluated in more than 3000 patients, and its efficacy, tolerability, and safety continue to be examined in an ongoing 5-year open-label extension study.

U.S. President Donald Trump last week blasted drugmakers and healthcare "middlemen" for making prescription medicines unaffordable for Americans as the administration said it would act to boost competition between pharmaceutical companies and test ways to pay for drugs based on their effectiveness. Aimovig (AIM'-oh-vig) is the first in a new class of long-acting drugs for preventing migraines. Trials of the medication showed many patients experiencing at least a 50 percent reduction in the number of days they experienced a migraine. The most commonly reported adverse events through all trials have been injection site reactions and constipation. Teva's fremanezumab and Eli Lilly and Co.'s galcanezumab are both awaiting a decision, and Alder's eptinezumab NDA is expected later this year.

Preventive medications may be an option for around eight million Americans suffering from migraine, Amgen said. The company said it will pay most out-of-pocket costs for eligible patients with commercial insurance.

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