According to Verona Pharma, the FDA has accepted the company’s NDA for its nebulized ensifentrine (RPL554) for the treatment of COPD with a PDUFA target date of June 26, 2024. The company submitted the NDA for ensifentrine, a PDE3/PDE4 inhibitor, at the end of June 2023. Verona is also developing DPI and MDI formulations of ensifentrine.
Verona President and CEO David Zaccardelli commented, “We are pleased with the FDA’s acceptance of our NDA submission for ensifentrine for the maintenance treatment of COPD and look forward to continuing to work with them during their review. . . . Ensifentrine, if approved, is expected to be the first novel mechanism available for the maintenance treatment of COPD in more than 10 years. We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm. This NDA acceptance brings us a step closer to our goal of delivering ensifentrine to a broad population of patients suffering from COPD.”
Read the Verona Pharma press release.
