Mr. YT Song
Tel: +82 2 560 8011
Mezzion Pharma announces that it has conducted a Type C Meeting with the FDA Regarding the TOP Line Data from the FUEL Phase 3 Clinical Trial
SEOUL, South Korea, Oct. 10, 2019 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410: KOSDAQ) today announces that on Tuesday, October 8, 2019, Mezzion conducted the Type C meeting with the FDA in Silver Spring, Maryland.
The purpose of the Type C meeting was to receive FDA guidance on Mezzion's NDA submission. The meeting was very constructive, and the FDA was extremely helpful. Mezzion is now taking the necessary steps to prepare and submit an NDA based upon the results of the FUEL Phase 3 Clinical Trial and in accordance with the FDA's good guidance.
Udenafil is a unique PDE5i drug that was used in the FUEL Phase 3 Clinical Trial to treat single ventricle congenital heart disease (SVHD) patients with Fontan physiology. The drug was administered as an oral 87.5 mg tablet twice daily.
Mezzion Pharma Co. Ltd.
Mezzion Pharma is headquartered in South Korea. Mezzion Pharma and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly-listed pharmaceutical company in Korea on the Korean stock exchange under (140410: KOSDAQ).