Tezepelumab BLA is submitted to the FDA to treat severe asthma. Amgen + AstraZeneca

Amgen has announced its partner AstraZeneca submitted a Biologics License Application (BLA) to the 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 III trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo. 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 II and Phase III clinical trials. Tezepelumab targets and blocks the action of an epithelial cytokine called thymic stromal lymphopoietin (TSLP) which plays a key role across the spectrum of asthma inflammation. In NAVIGATOR, tezepelumab demonstrated exacerbation rate reduction irrespective of baseline eosinophil count and improvements in lung function measurements, asthma control and health-related quality of life compared to placebo. The most frequently reported adverse events for tezepelumab were nasopharyngitis, upper respiratory tract infection and headache. These results support the FDA Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.