
An answer from the FDA for a drug that could be a key maintenance treatment for patients with COPD is expected by June 26, 2024.
Verona Pharma said that the FDA has accepted its New Drug Application seeking the approval of ensifentrine for review, and set the June deadline for a response. Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combine bronchodilator and non-steroidal anti-inflammatory activities in one compound. If approved, it would be the first novel mechanism for the treatment of COPD in 10 years.
David Zaccardelli, PharmD, president and CEO of Verona Pharma, said the company is pleased with the news of the application’s acceptance.
“Hundreds of millions of people around the world are suffering from COPD,” Dr. Zaccardelli said. “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.”
Ensifentrine has already been studied as a treatment for other respiratory diseases, including asthma and cystic fibrosis. It is currently in phase 3 ENHANCE trials for both of those areas.