Verona Pharma Reports the US FDA Acceptance of NDA for Ensifentrine to Treat Chronic Obstructive Pulmonary Disease
Shots:
- The US FDA has accepted an NDA seeking approval of ensifentrine for the maintenance treatment of patients with COPD. The US FDA’s decision is expected on June 26, 2024
- The NDA was based on the P-III trials (ENHANCE-1 & 2) evaluating nebulized ensifentrine as monotx. or as an add-on to a LAMA/ LABA vs PBO in 763 & 790 patients with mod. to sev. COPD. The results showed an improvement in lung function and daily symptoms and reduced the rate of mod. to sev. COPD exacerbations
- The therapy was well-tolerated in a broad population of patients with mod. to sev. COPD. If Ensifentrine is approved, it is expected to be the first novel mechanism available for the maintenance treatment of COPD
Ref: Globenewswire | Image: Verona Pharma
Related News:- Nuance Pharma Initiates the First Patient Dosing of Ensifentrine in P-III for the Treatment of Chronic Obstructive Pulmonary Disease
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