FDA has accepted the NDA filing for ensifentrine for the maintenance treatment of COPD

The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of June 26, 2024, and is not currently planning to hold an advisory committee meeting to discuss the application.

“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,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “Hundreds of millions of people around the world are suffering with COPD. 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.”

The NDA included efficacy and safety data from Verona Pharma’s Phase III ENHANCE trials, in which ensifentrine demonstrated improvements in lung function and symptoms endpoints and substantially reduced the rate and risk of COPD exacerbations. Ensifentrine was well-tolerated in a broad population of subjects with moderate to severe COPD.