BRIEF— Alder BioPharmaceuticals files BLA for eptinezumab

Alder BioPharmaceuticals announced today that the company filed its Biologics License Application (BLA) for eptinezumab with the US Food and Drug Administration.

Eptinezumab is an investigational monoclonal antibody (MAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP).

If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a first-quarter 2020 commercial launch.

Migraine affects over 36 million Americans and is the third most disabling disease for people under the age of 50.

Alder says it understands the physical and emotional toll migraine can take and is gearing up for a transformational year ahead.