Verona Pharma plc has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for approval of ensifentrine for the maintenance treatment of 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,” says David Zaccardelli, president and CEO of Verona Pharma, in a release. “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.” 

“We are immensely proud to see ensifentrine’s progress with the FDA. This exciting milestone affirmed our confidence in ensifentrine’s potential to redefine the COPD treatment globally,” says Mark Lotter, founder and CEO of Nuance Pharma, partner to Verona Pharma, in a release. “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.”

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 6, Nuance Pharma announced the first patient in for the ENHANCE-China phase 3 clinical trial.

The NDA contains data from the positive phase 3 ENHANCE studies and other ensifentrine clinical studies including data from approximately 3,000 subjects.