Novartis (NYSE:NVS) said today that a committee for the European Medicines Agency has recommended that the regulatory agency approve Aimovig, a self-administered drug designed to prevent migraines in adults who have at least four migraine days each month.
The drug is the first of a new class of medicines, called CGRP inhibitors. It’s a monoclonal antibody that blocks the receptor for a protein that is linked to migraine pain, known as the calcitonin gene-related peptide. Just last month Aimovig, developed by Amgen (NSDQ:AMGN), won FDA approval in the U.S.
The product is designed to be administered once every four weeks using an auto-injector device. Novartis and Amgen plan to co-commercialize Aimovig in the U.S., but Amgen has exclusive rights in Japan. Novartis owns exclusive rights to commercialize in the rest of the world, including the E.U.
The EMA’s Committee for Medicinal Products for Human Use made its decision based on data from four Phase II and Phase III trials. Altogether, the late-stage trials enrolled more than 2,600 patients, according to Novartis. Across these studies, 50% of patients experiencing episodic migraine saw their number of migraine days cut in half after taking Aimovig.
“We are excited to be one step closer to bringing the first targeted migraine prevention therapy to patients in Europe,” Novartis Pharma CEO Paul Hudson said in prepared remarks. “If approved, patients suffering from migraine will no longer have to rely on preventive treatments repurposed from other diseases that are often associated with poor tolerability and lack of efficacy. With Aimovig, physicians may soon provide these patients with an option for a safe, effective and well-tolerated migraine prevention treatment.”
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