European Commission approves dupilumab for COPD with type 2 inflammation

Key takeaways:

• The European Commission based dupilumab’s approval on data from the phase 3 BOREAS and NOTUS trials.
• The FDA is expected to make a decision on dupilumab for COPD by Sept. 27.

The European Commission announced approval of dupilumab for treating adults with uncontrolled COPD with type 2 inflammation, according to a press release from Regeneron.

In the release, the company highlighted that this marks the first approval of dupilumab (Dupixent; Regeneron, Sanofi) for COPD in the world.

The European Commission based its decision on dupilumab, in part, on data from two multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 studies: BOREAS and NOTUS. Both studies included patients primarily on triple therapy.

In the BOREAS study, adults with moderate/severe COPD and type 2 inflammation (blood eosinophil count ≥ 300 cells/μL) receiving 300 mg of dupilumab every 2 weeks had a 30% lower annualized rate of exacerbations and better lung function at 52 weeks vs. placebo.

Dupilumab also improved patients’ quality of life and symptom burden. At week 52, researchers observed a least-squares mean difference of –3.4 (95% CI, –5.5 to –1.3) in St. George Respiratory Questionnaire (SGRQ) scores between the groups and a least-squares mean difference of –1.1 (95% CI, –1.8 to –0.4) in Evaluating Respiratory Symptoms (E-RS): COPD scores as well.

The NOTUS study also found that adults with moderate to severe COPD and type 2 inflammation in the dupilumab vs. placebo group had a decrease in the annualized rate of moderate or severe exacerbations by 34% and better lung function at 52 weeks.

Patients receiving dupilumab additionally had improved measures of quality of life and symptom burden.

By week 52, baseline SGRQ scores improved to a greater degree among those receiving dupilumab vs. placebo (least-squares mean difference, –3.4 points; 95% CI, –5.8 to –0.9). The dupilumab group also had larger improvements in the E-RS: COPD total score at week 52 vs. the placebo group (least-squares mean difference, –0.6; 95% CI, –1.4 to 0.2).

Through the NOTUS study, researchers confirmed findings from the BOREAS study.

In both trials, researchers found that the dupilumab and placebo groups had comparable rates of treatment-emergent adverse events.

“With today’s approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils,” Paul Hudson, CEO of Sanofi, said in the release. “We look forward to working with other regulators around the world as quickly as possible to bring this novel treatment approach to patients in more countries.”

The FDA’s target action date for dupilumab to treat adults with uncontrolled COPD with type 2 inflammation was originally June 27, but was pushed to Sept. 27 because the administration “requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials,” Regeneron said in a release.

References:

• Bhatt SP, et al. N Eng J Med. 2023;doi:10.1056/NEJMoa2303951.
• Bhatt SP, et al. N Eng J Med. 2024;doi:10.1056/NEJMoa2401304.
• Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation. https://investor.regeneron.com/news-releases/news-release-details/update-fda-priority-review-dupixentr-dupilumab-treatment-copd. Published May 31, 2024. Accessed July 3, 2024.