U.S. Food and Drug Administration Accepts Biologics License Application for Eptinezumab
ALDER BIOPHARMACEUTICALS INC (ALDR)
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Source: GlobeNewswire
BOTHELL, Wash., April 22, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ: 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 depres
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