Udenafil filed with FDA for single ventricle heart disease.- Mezzion Pharma

Mezzion Pharma has submitted a New Drug Application (NDA) to the FDA for udenafil to improve the physiology of patients aged at least 12 years with single ventricle heart disease (SVHD) who have undergone the Fontan operation. The NDA is supported by data from hundreds of studies completed over the last 2 decades, including the pivotal phase III FUEL trial, which evaluated the efficacy and safety of udenafil in 400 adolescent patients who underwent the Fontan operation. Patients were randomized 1:1 to receive either udenafil 87.5mg orally twice daily or placebo plus standard therapy.

The primary end point was the change in exercise capacity from baseline to week 26, as measured by maximal VO2 at maximum exercise effort. Results from the trial showed that udenafil was not associated with statistically significant improvements in oxygen consumption at peak exercise, however analysis at ventilatory anaerobic threshold showed significant improvements in submaximal exercise performance. Additionally, findings of the study showed the treatment was not associated with changes in myocardial performance index, log-transformed reactive hyperemia index, or serum brain-type natriuretic peptide levels.