According to Verona Pharma, the FDA has approved the company’s NDA for Ohtuvayre (ensifentrine, RPL554), a PDE3/PDE4 inhibitor delivered via jet nebulizer, for the treatment of COPD. Verona submitted the NDA for ensifentrine in June 2023, and the FDA accepted the NDA for review in September 2023. The company says that Ohtuvayre will be available to patients in the US “through an exclusive network of accredited specialty pharmacies.”
Verona President and CEO David Zaccardelli commented, “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. 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.”
Read the Verona Pharma press release.
