U.S. FDA Prioritizes Tezepelumab Review to Treat Asthma

The United States FDA has credited the biologics license applications (BLA) and has vouched for priority review for Tezepelumab, an innovative therapeutic solution developed by AstraZeneca and Amgen for treating patients who have asthma.

Tezepelumab is a highly potent human monoclonal antibody. It is also observed to be the first and only biologic to have consistent and significant effects in reducing asthma exacerbations in a vast population across the Phase 2 and Phase 3 clinical trials. AstraZeneca has mentioned that the approval of BLA was based on the PATHFINDER clinical trials results along with the pivotal NAVIGATOR Phase 3 trial results. Tezepelumab showcased superiority throughout all the primary and key secondary endpoints compared to the placebo effect observed in the NAVIGATOR trial.

This particular trial consisted of patients suffering from uncontrolled asthma. These patients are currently delivered medium or high doses of inhaled corticosteroids (ICS) coupled with at least one additional controller dose of medicine either accompanied with or without oral corticosteroids (OCS).The absence of clinically relevant differences in the safety results has been reported among the Tezepelumab and the placebo categories during the NAVIGATOR trial.

However, some of the concerning adverse effects of Tezepelumab treatment included an upper respiratory tract infection, headache, and nasopharyngitis. AstraZeneca’s R&D executive vice president Mene Pangalos said that the favorable decision would enhance the company’s efforts to deliver the first-in-class medicine for the compromised patients, many currently in an uncontrolled situation exposed to the risk of asthma attacks.