Alder Biopharmaceuticals, Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. 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. Eptinezumab has been evaluated in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic migraine prevention. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages. Top-line results from the PROMISE 1 and PROMISE 2 Phase 3 clinical trials were presented at the American Association of Neurology (AAN) and American Headache Society (AHS) meetings in the second quarter of 2018 and will be published in future peer-reviewed publications.