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FDA Approves Amgen’s Migraine Drug

(Source: www.forbes.com)

The U.S. Food and Drug Administration has approved Amgen ’s erenumab (which it’s calling Aimovig) to prevent migraines.

“We feel pretty strongly this is a huge opportunity to help patients with a targeted, migraine specific medication that’s broadly efficacious, and can be administered in a patient-friendly way,” said Rob Lenz, VP, development at Amgen who lead the development of Aimovig. The drug’s list price is $6,900 per year, or $575 per monthly injected dose, lower than many market-watchers expected. Amgen is commercializing Aimovig with Novartis in the U.S.

That Aimovig is the first drug approved in a new class of migraine drugs targeting a protein called CGRP class is “key,” Cowen analyst Steve Scala wrote in a note to clients earlier this week, “as there will likely be several competitors and differentiation does not appear substantial.”

The competition: Alder Biopharmaceuticals’ eptinezumab (an infusion patients get every three months), Lilly’s galcanezumab (a monthly injection) and Teva’s fremanezumab (a monthly or quarterly injection). Lenz emphasized Aimovig’s convenience for patients as a once-a-month injection, and that the drug proved effective in people who have migraines at least four days a month, people who have migraines at least half the days out of a month, and people who tried at least two migraine-prevention drugs before to no avail.

“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”

More Info: www.forbes.com

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