FDA grants breakthrough designation to tezepelumab for COPD

Tezepelumab has received an FDA breakthrough therapy designation as a maintenance treatment for patients with moderate to very severe COPD characterized by an eosinophilic phenotype, according to an Amgen press release.

Tezepelumab (Tezspire; Amgen, AstraZeneca) is currently approved by the FDA as an add-on maintenance treatment of adults and children aged 12 years and older with severe asthma.

The COPD designation was supported by the multicenter, randomized, double-blind, placebo-controlled phase 2a COURSE study, data from which Healio previously reported on at this year’s American Thoracic Society International Conference.

In this study, researchers found that patients with moderate to very severe COPD receiving 420 mg tezepelumab every 4 weeks (n = 165) vs. placebo (n = 168) had a 17% decrease in the annualized rate of exacerbations.

Dividing the cohort based on blood eosinophil count revealed a larger drop in exacerbation rate with tezepelumab, with decreases of 37% (rate ratio = 0.63; 95% CI, 0.43-0.93) in the 150 cells/μL or more count group, 34% (rate ratio = 0.66; 95% CI, 0.42-1.04) in the at least 150 cells/μL to less than 300 cells/μL count group and 46% (rate ratio = 0.54; 95% CI, 0.25-1.15) in the 300 cells/μL or more count group.

In terms of safety, patients in the tezepelumab group and patients in the placebo group experienced a comparable number of adverse events and serious adverse events.

“The FDA’s decision to grant breakthrough therapy designation for tezepelumab in COPD represents a significant milestone in our commitment to advancing effective treatment options for patients with moderate to very severe disease,” Sharon Barr, PhD, executive vice president and head of biopharmaceuticals research and development at AstraZeneca, and Jay Bradner, MD, executive vice president of research and development and chief scientific officer at Amgen, told Healio in a joint statement. “This recognition validates our belief in tezepelumab and its promise as a new treatment for COPD.”

Breakthrough therapy designation is granted to accelerate development and regulatory review of investigational drugs that are intended to treat serious or life-threatening diseases and conditions.

“As we advance our clinical development program, we look forward to working with the FDA to bring this potential therapy to these patients as quickly as possible,” Barr and Bradner continued.

The release said phase 3 study planning “remains on track.”