FDA grants priority review to dupilumab for COPD with type 2 inflammation

The FDA has granted priority review to dupilumab to treat adults with uncontrolled COPD with type 2 inflammation, according to a manufacturer-issued press release.

The FDA based this decision, in part, on data from the two phase 3 trials (BOREAS and NOTUS), which demonstrated that dupilumab (Dupixent; Regeneron, Sanofi) decreases exacerbation rate in this patient population.

As Healio previously reported, the BOREAS trial found that adults with moderate or severe COPD receiving 300 mg of dupilumab every 2 weeks had a 30% lower annualized rate of exacerbations vs. placebo.

Similarly, in the NOTUS trial, receipt of dupilumab every 2 weeks lowered the rate of exacerbations by 34% at week 52 vs. placebo.

Lung function also improved in these trials with use of dupilumab. In the BOREAS trial, dupilumab improved pre-bronchodilator FEV₁ by 83 mL (95% CI, 42 mL-125 mL) at 12 weeks compared with placebo, and this level of improvement was again found in the dupilumab group at 52 weeks (83 mL; 95% CI, 38 mL-128 mL).

From baseline to week 12 in the NOTUS trial, researchers found that patients receiving dupilumab vs. placebo also demonstrated better lung function (pre-bronchodilator FEV₁, 139 mL vs. 57 mL; P = .0001), which continued to be the case at week 52 (115 mL vs. 54 mL; P = .0182).

Additionally, the release noted that both trials had comparable safety results that “were generally consistent with the known safety profile” of the drug.

If approved, this will be the first biologic therapy for patients with COPD, according to the release. The FDA set a target action date of June 27.