Alder 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 BLA on February 21, and continues to expect to receive a PDUFA action date within 74 days following the submission. If the FDA grants approval of eptinezumab, Alder anticipates a Q1 2020 commercial launch.
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