Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA

THOUSAND OAKS, Calif., May 10, 2021 —Amgen (NASDAQ: AMGN) today announced its partner AstraZeneca (NASDAQ: AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial; demonstrating a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.¹ Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials. READ MORE