Alder BioPharma BLA for eptinezumab accepted by FDA
Alder BioPharma (NASDAQ:ALDR) BLA application for eptinezumab, a monoclonal antibody for the prevention of migraines, has been accepted by the FDA.
Administered intravenously, eptinezumab targets and suppresses calcitonin gene-related peptide, which is believed to play a role in migraine attacks. The BLA is supported by two Phase 3 clinical trials where eptinezumab met the primary endpoint of mean change from baseline in monthly migraine days over the 12-week treatment period, compared to placebo.
“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,” Bob Azelby, Alder’s president and CEO, said in a statement.
Should the FDA approve eptinezumab, Alder anticipates commercial launch in the first quarter of 2020.