Posted by Michael Wonder on 23 Apr 2019
U.S. FDA accepts biologics license application for eptinezumab
22 April 2019 - Alder BioPharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license application for eptinezumab.
Eptinezumab is an investigational monoclonal antibody, administered intravenously, for migraine prevention targeting the calcitonin gene-related peptide and is Alder’s lead commercial candidate. The company submitted its application on 21 February 2019 and continues to expect to receive a Prescription Drug User Fee Act action date within 74 days following the submission.
If the FDA grants approval of eptinezumab, Alder anticipates a Q1 2020 commercial launch.
