The FDA has granted Priority Review for tezepelumab and accepted a Biologics License Application (BLA) for patients with asthma.
A release from the manufacturer described the drug as an “investigational, potential first-in-class human monoclonal antibody.” It targets and blocks the thymic stromal lymphopoietin, which the release said is a “key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic, and other types of airway inflammation associated with severe asthma.
The BLA was based on results from the PATHFINDER clinical trial program, which included the phase 3 NAVIGATOR trial. The trial included more than 1,000 patients between the ages of 18 and 80 and younger patients between the ages of 12 and 17, with severe, uncontrolled asthma, who had been previously treated with medium-or high-dose inhaled corticosteroids and one additional controller medication with or without OCS. The release noted that the trial met its primary endpoint with tezepelumab added to the standard of care, showing a reduction in annualized asthma exacerbation rate over 52 weeks in the overall patient population compared to placebo and standard of care.
David M. Reese, MD, executive vice president of Research and Development at Amgen, said in the release that there is a “high unmet medical need” for patients with severe asthma.
“We are proud to advance an innovative first-in-class monoclonal antibody that targets the top inflammatory cascade and represents a potentially transformative treatment option for a broad population of patients with severe asthma,” Reese added.
The release noted there were no clinically meaningful differences in safety from the study between the two groups. The most frequently reported adverse events in the tezepelumab arm were nasopharyngitis, upper respiratory tract infection, and headache.
Results of the NAVIGATOR trial were published in the New England Journal of Medicine. Tezepelumab had been previously granted Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype.
The FDA has set a Prescription Fee Act goal date for a decision for the first quarter of 2022.