Source – Verona Pharma
On June 27, 2023, Verona Pharma announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ensifentrine, a potential treatment for patients with chronic obstructive pulmonary disease (COPD). Ensifentrine is a unique compound that combines bronchodilator and non-steroidal anti-inflammatory activities by selectively inhibiting the enzymes phosphodiesterase III and IV. If approved, it would be the first innovative treatment option for COPD in over a decade.
“Millions of symptomatic COPD patients in the US are in urgent need of new treatment options. 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.”
– David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma
The NDA includes data from the positive Phase III ENHANCE studies, as well as other clinical studies involving ensifentrine, which encompass approximately 3,000 subjects.
