Amgen Submits BLA to The FDA For Erenumab

Amgen announced that it has submitted the BLA (Biologics License Application) for Erenumab along with the data from pivotal studies in patients with episodic and chronic migraine to the USFDA. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor.

Amgen executive VP of R&D, Sean E. Harper said that people with migraine lose a substantial part of their lives enduring or managing the disease, which takes time away from their loved ones, social activities and workplace responsibilities. 3.5 million Americans currently take a preventive treatment to reduce their number of migraine days, yet 80 percent of those discontinue these treatments within one year. This application represents a long-awaited step towards addressing the unmet need faced by the migraine community through the potential delivery of erenumab, which has demonstrated strong efficacy, safety and tolerability in patients with episodic and chronic migraine.