FDA Grants Priority Review for AstraZeneca Asthma Biologic

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from FDA, the company announced in a July 8, 2021 press release. The biologic is being developed by AstraZeneca in collaboration with Amgen. According to the press release, tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials.

“This decision brings us a step closer to delivering a much-needed, first-in-class medicine for asthma patients, many of whom remain uncontrolled and at risk of asthma attacks despite the availability of inhaled and biologic medicines,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, in the press release. “Tezepelumab has demonstrated reductions in exacerbations irrespective of blood eosinophil counts, allergy status, and fractional exhaled nitric oxide, and [it] has the potential to transform treatment for a broad population of severe asthma patients.”

The BLA was based on results from the Pathfinder clinical trials program, including results from the pivotal Navigator Phase III trial. Results from the Navigator Phase III trial were published in The New England Journal of Medicine in May 2021.

Tezepelumab received Breakthrough Therapy Designation for patients with severe asthma, without an eosinophilic phenotype in September 2018.

Source: AstraZeneca