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The financing will fund FUEL-2, Mezzion's confirmatory phase 3 trial, along with future commercialization and regulatory submissions in other countries including Europe. Mezzion is looking to market JURVIGO® (udenafil), a highly selective, unique and potent PDE-5 inhibitor.
MZ101 (udenafil) is a phosphodiesterase type 5 inhibitor, improves measures of exercise performance at the ventilatory anaerobic threshold in individuals with fontan physiology.
Mezzion sought clarity on the critical elements of an additional clinical trial that may be needed to complete the NDA submission for Udenafil for Single Ventricle Heart Disease.
The FDA had previously granted Mezzion's request to designate udenafil for treatment of single ventricle congenital heart disease as a drug for a Rare Pediatric Disease.
The NDA submission, which totals nearly 100,000 pages, is supported by data from more than 700 documents including more than 200 studies that Mezzion has completed during the last 2 decades since its founding in 2002.
Subjects on udenafil therapy showed a statistically significant improvement in ventricular performance as measured by MPI as compared to subjects taking placebo over the same time period.