FDA Accepts Amgen BLA for Migraine Biologic

FDA has accepted an Amgen BLA for Aimovig (erenumab) for preventing migraine in patients experiencing four or more migraine days per month. If approved, Aimovig would be the first monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, the company says. The submission includes data from pivotal studies involving more than 2,600 patients experiencing four or more days of migraine per month. “Phase 2 and Phase 3 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 company says. “The safety profile of Aimovig was similar to placebo across all treatment arms in the Phase 2 and Phase 3 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.”