Verona Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule.
If approved, it is expected to be the first novel mechanism available for the treatment of COPD in over 10 years.
“Millions of symptomatic COPD patients in the US are in urgent need of new treatment options,” said Dr David Zaccardelli, President and Chief Executive Officer of Verona Pharma. “The NDA submission for ensifentrine is a significant milestone towards our goal of bringing this potential first-in-class therapy to COPD patients and we look forward to working with the FDA during their review.”
The NDA contains data from the positive Phase III ENHANCE studies and other ensifentrine clinical studies including data from approximately 3,000 subjects.
