Research & Development
Mezzion Pharma submits New Drug Application to US FDA for Udenafil
1 July 2020 -

Korea-based Mezzion Pharma Co Ltd (140410.KQ) has submitted a New Drug Application (NDA) to the United States Food and Drug Administration for the approval of udenafil intended to improve the physiology of patients 12 years of age and older with single ventricle heart disease who have undergone the Fontan operation, it was reported on Tuesday.

The product is orally administered and is a long acting highly selective phosphodiesterase-5 inhibitor. The NDA includes a request for Priority Review, which, if granted, is likely to reduce the FDA's review of the NDA to six months from the time of filing, compared to a standard review timeline of 10 months from filing.

The NDA submission is based on the data from over 700 documents, including more than 200 studies that the company has completed during the last two decades since its founding in 2002. The NDA package includes a pivotal Phase three clinical study conducted globally in collaboration with the Pediatric Heart Network. The study included treatment of 400 male and female adolescents from 30 Pediatric Heart Network and auxiliary sites throughout the United States, Canada and the Republic of Korea.