Posted by Michael Wonder on 23 Feb 2019
Alder BioPharmaceuticals submits biologics license application to the U.S. FDA for eptinezumab
22 February 2019 - Significant milestone toward the commercialisation of eptinezumab, the first quarterly infusion therapy for migraine prevention.
Alder BioPharmaceuticals today announced it has submitted a biologics license application (BLA) to the U.S. FDA for eptinezumab. Eptinezumab is an investigational monoclonal antibody for migraine prevention targeting the calcitonin gene-related peptide and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch.
Eptinezumab has been evaluated in several global, randomised, 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, open-label safety study, pharmacokinetic comparability study and chemistry, manufacturing, and controls data packages.
