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FDA Gives Green Light to Ensifentrine for Maintenance Treatment of COPD in Adults
The dual PDE3/PDE4 inhibitor is the first inhaled product with a novel mechanism of action approved for COPD in 2 decades and is delivered via standard jet nebulizer.
The FDA has approved ensifentrine (Ohtuvayre; Verona Pharma) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.1
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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 (NCT04535986), which included 2 replicate randomized, double-blind, placebo-controlled, multicenter trials (ENHANCE-1 [NCT04542057] and ENHANCE-2 [NCT04778397]). These trials analyzed the efficacy of nebulized ensifentrine on lung function, quality of life, symptoms, and exacerbations in adults with COPD.2 The FDA accepted Verona Pharma’s new drug application filing for ensifentrine in August 2023.2,3
This is the first inhaled product with a novel mechanism of action available for maintenance COPD treatment in over 20 years.1 The researchers noted that their findings showed that ensifentrine is “…a valuable and complementary addition to the limited available treatment mechanisms for patients with COPD.”2
"The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre's novel profile can change the treatment paradigm for COPD," said David Zaccardelli, PharmD, president and CEO of Verona Pharma. "We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms."1
The phase 3 ENHANCE trials analyzed individuals with moderate to severe symptomatic COPD, who were aged 40 to 80 years, at 250 research centers across 17 countries from September 2020 to December 2022.2 Consequently, 760 participants in the ENHANCE-1 trial and 789 in ENHANCE-2 were randomly assigned and treated; of each study population, 69% and 55% received concomitant long-acting muscarinic antagonists, respectively.
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.
Ensifentrine was well tolerated in both trials, with a similar proportion of adverse events reported in both treatment groups. In the ENHANCE-1 trial, 38.4% of participants taking ensifentrine and 36.4% of participants taking placebo reported treatment-emergent adverse events (TEAEs). Similarly, in the ENHANCE-2 trial, the ensifentrine (35.3%) and placebo (35.4%) groups reported similar proportions of TEAEs.
"Ensifentrine significantly improved lung function in both trials, with results supporting exacerbation rate and risk reduction in a broad COPD population and in addition to other classes of maintenance therapies," the authors concluded.
