FDA Panel Votes on New Combination Therapy for Asthma
The vote was mixed when the data was reviewed for younger patients.
The vote was mixed when the data was reviewed for younger patients.
Ensifentrine (RPL554) is a first-in-class, dual phosphodiesterase (PDE) 3 and 4 inhibitor with combined bronchodilator and anti-inflammatory actions.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
The combination therapy significantly reduced the risk of severe exacerbations and improved lung function.
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
Data mining resulted in 2006 reports of anaphylaxis related to the use of 5 mAbs.
The BLA submission is supported by data from the PATHFINDER clinical program.