BOTHELL, Wash:   Alder BioPharmaceuticals, Inc. (ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb), administered intravenously, for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. The company submitted its BLA on February 21, 2019 and continues to expect to receive a Prescription Drug User Fee Act (PDUFA) action date within 74 days following the submission. If the FDA grants approval of eptinezumab, Alder anticipates a Q1 2020 commercial launch.

“Migraine is far more than a headache, it’s a serious neurological disease with a debilitating impact to patients that can lead to other issues including depression, anxiety, and sleep disturbances,” said Bob Azelby, Alder’s president and chief executive officer. “The FDA’s acceptance of our BLA is an important milestone, and the company remains focused on supporting the application review for the first quarterly infusion therapy for patients suffering from episodic and chronic migraine. In the meantime, we continue to make substantial progress scaling our medical, manufacturing and commercial infrastructure to enable a successful launch of eptinezumab for migraine patients, if approved.“

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, an open-label safety study, a pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages. The safety profile of eptinezumab was similar to placebo across all treatment arms in the Phase 3 studies. The most common adverse events across the studies was nasopharyngitis. 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 are planned for publication in 2019.