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.

Mr. Mark Lotter, founder and CEO of Nuance Pharma, commented: "We are immensely proud to see ensifentrine's progress with the FDA. This exciting milestone affirmed our confidence in ensifentrine's potential to re-define the COPD treatment globally. Like our partner Verona, we are highly committed to bringing this first-in-class therapy to patients in Greater China. Together, we aim to significantly improve the lives of millions coping with this challenging disease."

"Millions of symptomatic COPD patients in the US are in urgent need of new treatment options," said David Zaccardelli, Pharm. D., 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 3 ENHANCE studies and other ensifentrine clinical studies including data from approximately 3,000 subjects.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize ensifentrine in Greater China. On April 6th 2023, Nuance Pharma announced first patient in (FPI) for the ENHANCE-China Phase III clinical trial