Posted by Michael Wonder on 10 May 2021
Amgen announces tezepelumab biologics license application submitted to U.S. FDA
10 May 2021 - Potential first in class medicine blocking TSLP, an epithelial sytokine.
Amgen today announced its partner AstraZeneca submitted a biologics license application to the U.S. 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, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate in patients with severe, uncontrolled asthma compared to placebo.
