Verona Pharma Announces FDA Has Accepted NDA Filing for Ensifentrine for the Maintenance Treatment of COPD
Verona Pharma plc recently announced the US FDA has accepted for review the company’s New Drug Application (NDA) seeking approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (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, PharmD, 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 3 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.
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. The company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2. In the third quarter of 2023, the US FDA accepted for review the company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (DPI) and pressurized metered-dose inhaler (pMDI). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, visit www.veronapharma.com.
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