The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.
The FDA has accepted Amgen’s Biologics License Application (BLA) and granted priority review for tezepelumab to treat patients with severe, uncontrolled asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is during the first quarter of 2022.
Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial-cell–derived cytokine implicated in asthma.
The BLA was based on results from the PATHFINDER clinical trial program, including results from the pivotal NAVIGATOR phase 3 trial. Investigators in the NAVIGATOR study found that patients with severe, uncontrolled asthma who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life than those who received placebo. Results were published May 13, 2021 in the New England Journal of Medicine.
The most frequently reported adverse events with tezepelumab were nasopharyngitis, upper respiratory tract infection and headache.
The FDA had granted Breakthrough Therapy Designation to Tezepelumab in September 2018.
“Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” David M. Reese, M.D., executive vice president of research and development at Amgen said in a statement.
About 25 million Americans have asthma. This equals to about 1 in 13 Americans, including 8% of adults and 7% of children, according to Asthma and Allergy Foundation of America