FDA Approves Ensifentrine for Maintenance Treatment of COPD in Adults: Daily Dose

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On June 27, 2024, we reported on the US Food and Drug Administration (FDA) approval of ensifentrine (Ohtuvayre; Verona Pharma) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

The approval

Ensifentrine is a dual phosphodiesterase (PDE)3 and PDE4 inhibitor delivered directly to the lungs through a standard jet nebulizer. The approval was based on findings from the phase 3 ENHANCE trials that analyzed the efficacy of nebulized ensifentrine on lung function, quality of life, symptoms, and exacerbations in adults with COPD.

Overall, ensifentrine significantly improved lung function across both trials. Compared to placebo, ensifentrine significantly improved average forced expiratory volume in 1 second area under the curve at 0 to 12 hours in both the ENHANCE-1 (87 mL; 95% CI, 55-119) and ENHANCE-2 (94 mL; 95% CI, 65-124) trials (both P < .001). Conversely, at week 24, ensifentrine significantly improved the quality of life and symptoms compared with placebo in the ENHANCE-1 study population but not in the ENHANCE-2 study population.

However, the researchers found that ensifentrine treatment reduced the rate of moderate or severe exacerbations over 24 weeks in ENHANCE-1 (rate ratio [RR], 0.64; 95% CI, 0.40-1.00; P = .050) and ENHANCE-2 (RR, 0.57; 95% CI, 0.38-0.87; P = .009) vs the placebo group; it also increased time to first exacerbation among the ENHANCE-1 (HR, 0.62; 95% CI, 0.39-0.97; P = .038) and ENHANCE-2 (HR, 0.58; 95% CI, 0.38-0.87; P = .009) populations.

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