The Food and Drug Administration has accepted the New Drug Application for ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Ensifentrine is a first-in-class, dual phosphodiesterase 3 and 4 inhibitor with combined bronchodilator and anti-inflammatory actions. The application for regulatory approval included data from two phase 3 trials, ENHANCE-1 (ClinicalTrials.gov Identifier: NCT04535986) and ENHANCE-2 (ClinicalTrials.gov Identifier: NCT04542057), which evaluated the efficacy and safety of nebulized ensifentrine as monotherapy or as an add-on to a long-acting muscarinic antagonist or a long-acting beta-agonist in patients with moderate to severe COPD.
Findings showed that treatment with ensifentrine demonstrated improvements in lung function and daily symptoms and reduced the rate of moderate to severe COPD exacerbations, compared with placebo.
“Ensifentrine, if approved, is expected to be the first novel mechanism available for the maintenance treatment of COPD in more than 10 years,” said David Zaccardelli, PharmD, President and CEO Chief Executive Officer of Verona Pharma. “We believe its bronchodilator and nonsteroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
A Prescription Drug User Fee Act target action date of June 26, 2024 has been assigned to the application.
This article originally appeared on MPR
Verona Pharma announces the US FDA has accepted the New Drug Application filing for ensifentrine for the maintenance treatment of COPD. News release. Verona Pharma. September 11, 2023. www.globenewswire.com/news-release/2023/09/11/2740487/0/en/Verona-Pharma-Announces-the-US-FDA-has-Accepted-the-New-Drug-Application-Filing-for-Ensifentrine-for-the-Maintenance-Treatment-of-COPD.html.