Verona Pharma Receives FDA Acceptance for New Drug Application of Ensifentrine as COPD Maintenance Treatment
Monday, September 11, 2023
Verona Pharma, trading on Nasdaq as VRNA, has announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) with ensifentrine. The FDA has set a target action date for June 26, 2024, and no advisory committee meeting is currently planned to discuss the application.
David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, expressed the company's satisfaction with the FDA's acceptance of their NDA submission. If approved, ensifentrine would be the first novel mechanism for COPD maintenance treatment in over a decade, potentially revolutionizing COPD treatment due to its bronchodilator and non-steroidal anti-inflammatory properties. The NDA submission included data from Verona Pharma's Phase 3 ENHANCE trials, which showed improvements in lung function, symptom management, and a significant reduction in COPD exacerbations among subjects with moderate to severe COPD. Ensifentrine was also well-tolerated in these trials.
