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# Verona NDA for COPD Drug Accepted
- URL: https://www.fdaweb.com/verona-nda-for-copd-drug-accepted/
- Published: 2023-09-18T12:00:00.000Z
- Updated: 2026-09-14T18:57:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155351

FDA has accepted for review a Verona Pharma NDA for ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The agency has set a user fee review action target date of 6/26/2024, and it is not currently planning to hold an advisory committee meeting to discuss the submission, according to the company.

The NDA is based on efficacy and safety data from Verona’s Phase 3 ENHANCE trials that demonstrated ensifentrine’s improved lung function, Verona says, adding that the trials met symptoms endpoints and “substantially reduced the rate and risk of COPD exacerbations.” Additionally, ensifentrine was well-tolerated in a broad population of subjects with moderate to severe COPD, it says.