The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for eptinezumab (Alder BioPharmaceuticals), an investigational calcitonin gene-related peptide (CGRP) inhibitor for migraine prevention.
Unlike other CGRP inhibitors, which are administered by subcutaneous injection, eptinezumab is administered as an intravenous (IV) infusion once every 12 weeks. According to the Company, the IV formulation “was designed for 100% bioavailability with high specificity and strong binding for rapid, robust, and sustained suppression of CGRP.”
The BLA is supported by data from two phase 3, placebo-controlled trials, PROMISE 1 and PROMISE 2, which evaluated eptinezumab for episodic and chronic migraine prevention, respectively. Additional efficacy and quality of life data will be presented at the 71st Annual Academy of Neurology (AAN) Meeting in Philadelphia being held May 4-10, 2019.
“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,” said Bob Azelby, Alder’s president and chief executive officer.
If approved, Alder expects to have eptinezumab available by the first quarter of 2020.
For more information visit Alderbio.com.