FDA Grants Breakthrough Therapy Designation to Tezepelumab for Severe Asthma

Officials with the FDA recently granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype, Amgen and AstraZeneca announced in a press release.

Tezepelumab is a potential first-in-class drug that blocks thymic stromal lymphopoietin (TSLP), an upstream modulator of multiple inflammatory pathways, according to Amgen. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control, according to the press release.

The designation is based on data from the phase 2b PATHWAY trial, which showed a significant reduction in the annual asthma exacerbation rate compared with a placebo over a 52-week treatment period.

The trial evaluated the efficacy and safety of 3-dose regimens of tezepelumab as an add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting beta-agonist with or without oral corticosteroids and additional asthma controllers compared with a placebo. Participants included patients with severe asthma independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers.

Overall, the data showed that annual asthma exacerbation rates were reduced by 62%, 71%, and 66% in the tezepelumab arms administered either 70 mg or 210 mg every 4 weeks or 280 mg every 2 weeks compared with a placebo, respectively.

“The Phase 2b PATHWAY trial data demonstrated tezepelumab’s promise as a novel therapeutic option for a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies,” David M Reese, MD, executive vice president of Research and Development at Amgen, said in a statement. “The Breakthrough Designation will give the opportunity to work closely with the FDA to bring tezepelumab to patients as quickly as possible.”

The most common adverse effects reported in the trial were asthma-related, nasopharyngitis, headaches, and bronchitis.

Tezepelumab is currently in development in the phase 3 PATHFINDER clinical trial program, which includes the 2 pivotal trials NAVIGATOR and SOURCE.

Reference

Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype [news release]. Amgen’s website. https://www.amgen.com/media/news-releases/2018/09/tezepelumab-granted-breakthrough-therapy-designation-by-us-fda-for-the-treatment-of-patients-with-severe-asthma-without-an-eosinophilic-phenotype/. Accessed September 10, 2018.