Company: Verona Pharma
Indication: Maintenance therapy for patients with chronic obstructive pulmonary disease (COPD).
On September 11, 2023, Verona Pharma announced that the U.S. FDA has accepted the New Drug Application for Ensifentrine for the maintenance treatment of COPD.
The NDA includes efficacy and safety data from Verona Pharma's Phase 3 ENHANCE trial (with ENHANCE-1 and ENHANCE-2), in which Ensifentrine demonstrated improvements in pulmonary function and symptomatic endpoints, and a significant reduction in the incidence and risk of COPD exacerbations.Ensifentrine was well tolerated in patients with moderate to severe COPD.The FDA has assigned a target action date of June 26, 2024 for the Prescription Drug User Fee Act (PDUFA), and does not currently plan to convene an advisory committee meeting to discuss the application.
In the ENHANCE-1 trial, patients with moderate-to-severe COPD had a 40% lower rate of worsening within 24 weeks compared to the placebo group (p=0.0012); and in the ENHANCE-2 trial, the risk of worsening in patients with moderate-to-severe COPD compared to the placebo group - the - interval to first deterioration, was reduced by 41% (p=0.0008). And the safety profile was favorable, with only very few adverse events occurring in more than 1% of subjects and higher than in the placebo group.