Verona Pharma announced that it has submitted an NDA to the FDA for the nebulized formulation of ensifentrine (RPL554), a PDE3/PDE4 inhibitor, for the treatment of COPD. The company said that the submission is supported by data from the Phase 3 ENHANCE-1 and ENHANCE-2 trials, both of which met their primary endpoints. Verona is also developing DPI and MDI formulations of ensifentrine.
Verona CEO David Zaccardelli commented, “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.”
Read the Verona Pharma press release.
