Mezzion Pharma Co, a well-known biotech company announced the positive results from phase 3 FUEL trial. It was designed to access the safety and efficacy of udenafil for treating certain adolescents with congenital single ventricle heart disease (SVHD).
Although, Mezzion is prohibited in sharing specific data results at current time due to legal obligation, the company is looking well-ahead to publication of the full results in a peer reviewed journal and the presenting clinical trial data at a major scientific meeting later this year.
The FUEL Trial study included 400 male and female adolescents with a single functional ventricle who had earlier undergone Fontan surgical palliation. Participants were assembled from a total of 30 Pediatric Heart Network (PHN) and auxiliary sites throughout the US, Canada, and Korea. The PHN is sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.
As per the reports received, results from FUEL trial and the safety data collected about the drug candidate over other clinical studies, Mezzion Pharma look forward to submit a New Drug Application to the US Food and Drug Administration for seeking approval for the usage of udenafil for treating adolescents with SVHD who have undergone Fontan palliation.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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