FDA accepts Amgen’s Aimovig BLA for migraine
Amgen announced that the FDA has accepted for review the Biologics License Application (BLA) for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine.
"Migraine is a serious neurological disease that has a substantial economic burden for both patients and the healthcare system, yet it continues to be under recognized and under treated," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are pleased to advance Aimovig, our migraine-specific preventive therapy, to help address the unmet need in this community and potentially mitigate the overall burden of this disease for patients who have already tried other therapeutic options."
The BLA for Aimovig includes data from pivotal studies of more than 2,600 patients experiencing four or more days of migraine per month. Phase II and phase III clinical studies of Aimovig versus placebo have demonstrated a reduction in the number of migraine-affected days, disability and acute medication use for patients with episodic and chronic migraine. The safety profile of Aimovig was similar to placebo across all treatment arms in the phase II and phase III studies for up to six months. The most common adverse events across the studies were upper respiratory tract infection, injection site pain, nausea and nasopharyngitis.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018.
Aimovig will be jointly commercialized in the U.S. by Amgen and Novartis.