FDA approves dupilumab for COPD with type 2 inflammation

The FDA has granted approval to dupilumab for treating adults with poorly controlled COPD with type 2 inflammation, according to a manufacturer-issued press release.

As Healio previously reported, the FDA granted priority review to dupilumab (Dupixent; Regeneron, Sanofi) in February.

According to the release, this decision on dupilumab was, in part, based on findings from the multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 BOREAS and NOTUS studies. Both studies included patients primarily on triple therapy.

A pooled analysis of these two trials presented at this year’s European Respiratory Society International Congress showed that 300 mg dupilumab every 2 weeks led to improvement and was safe in current/former smokers with moderate to severe COPD and type 2 inflammation (blood eosinophil count ≥ 300 cells/μL) at week 52.

Compared with patients on placebo, patients on dupilumab showed a 31% decrease in the annualized moderate/severe exacerbation rate at week 52 (0.794 vs. 1.156; nominal P < .0001), according to pooled analysis results.

Between baseline and week 12, researchers also observed a larger positive change in prebronchodilator FEV₁ in the dupilumab vs. the placebo group (least squares mean difference, 83 mL; nominal P < .0001). The same was true when analyzing changes between baseline and week 52, with a larger change observed among those receiving dupilumab (least squares mean difference, 73 mL; nominal P < .0001).

In terms of safety, a similar proportion of patients reported a treatment-emergent adverse event in both groups from the pooled analysis (dupilumab, 72.1% vs. placebo, 71%).

“With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations,” Paul Hudson, CEO of Sanofi, said in the release.

Notably, dupilumab was approved for this patient population by the European Commission in July.