FDA approves Ohtuvayre as maintenance treatment for COPD
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Key takeaways:
- The FDA based ensifentrine’s/Ohtuvayre’s approval on data from the phase 3 ENHANCE trials.
- The launch of Ohtuvayre is expected in the third quarter of 2024.
The FDA has approved the phosphodiesterase enzyme 3 and 4 inhibitor ensifentrine, now named Ohtuvayre, for treating adults with COPD, according to a manufacturer-issued press release.
As Healio previously reported, David Zaccardelli, PharmD, president and CEO of Verona, highlighted that Ohtuvayre (Verona Pharma) is a nebulized, maintenance treatment “that is a bronchodilator and a nonsteroidal anti-inflammatory.”
The FDA based its decision on Ohtuvayre, in part, on data from the global, multicenter, randomized, double blind, parallel-group, placebo-controlled phase 3 ENHANCE trials, which found that 3 mg of twice-daily Ohtuvayre improved measures of lung function, quality of life and exacerbation rate over 12 or 24 weeks in adults with moderate to severe COPD.
Combining both trial cohorts, 62% of patients were on LABA or LAMA background therapy, and 18% were on LABA or LAMA plus inhaled corticosteroids.
In both trials, patients receiving Ohtuvayre showed a significant increase in the primary endpoint of average FEV1 area under the curve over 12 hours compared with placebo (ENHANCE-1, + 87 mL; ENHANCE-2, + 94 mL; P < .001 for both).
Trial data published in the American Journal of Respiratory and Critical Care Medicine and presented at the 2023 American Thoracic Society International Conference also showed that the Ohtuvayre group reported a similar number of adverse events as the placebo group.
“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,” Zaccardelli said in the release.
Notably, the Midwest Comparative Effectiveness Public Advisory Council recently voted on the net health benefit of Ohtuvayre plus maintenance therapy at a public meeting, and 11 of 15 members believed current evidence was adequate in showing this benefit.