
Verona Pharma is seeking approval from the FDA for a drug the company said could be a key maintenance treatment for patients with COPD.
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 has submitted a New Drug Application (NDA) to the FDA for ensiphentrine and is awaiting the review from the agency. The application contains data from the positive phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) studies and other studies including data from about 3,000 subjects.
“Millions of symptomatic COPD patients in the U.S. are in urgent need of new treatment options,” Dr. Zaccardelli said. “The NDA submission for ensifentrine is a significant milestone toward our goal of bringing this first-in-class therapy to COPD patients, and we look forward to working with the FDA during their review.”
Ensifentrine has already been studied as a treatment for other respiratory diseases, including asthma and cystic fibrosis. It is currently in phase 2 studies for both of those areas.