Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle heart disease (SVHD) who have Fontan physiology was presented to the U.S. Food and Drug Administration (FDA) in a Type C meeting held on Thursday, December 16, 2021.
| SEOUL, South Korea and BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of a very large subgroup of patients with congenital single ventricle heart disease (SVHD) who have Fontan physiology was presented to the U.S. Food and Drug Administration (FDA) in a Type C meeting held on Thursday, December 16, 2021.
Mezzion Pharma is pleased to report that this newly presented data from the FUEL Trial is statistically significant and supports efficacy and clinical relevance for udenafil treatment of this very large subgroup, approximately 80% of the treatment population, who will most benefit from udenafil treatment. Mezzion Pharma is also pleased to report that the FUEL OLE Trial data supports and is believed to provide independent confirmatory evidence of reproducibility and durability of this efficacy for this very large subgroup. The FUEL Trial is a landmark study that evaluated the safety and efficacy of orally administered udenafil in 400 male and female adolescents with a single functional ventricle who had previously undergone Fontan surgical palliation. Study participants were drawn from a total of 30 Pediatric Heart Network http://www.pediatricheartnetwork.org/ (PHN) and auxiliary sites throughout the U.S., Canada, and Korea. In view of the positive analysis of the subgroup data from the FUEL Trial and FUEL OLE Trial, Mezzion Pharma continues to look forward to the FDA review process and to bringing a novel pharmacotherapeutic option to this unique Fontan patient population. About the Fontan Procedure and Subsequent Expectations While the Fontan procedure creates a stable circulation, the risk of hospitalization and cardiac death rises significantly in the second and third decades after Fontan completion, a risk that is associated with a decline in exercise capacity. The Fontan circulation is also associated with non-cardiac complications such as protein-losing enteropathy, plastic bronchitis, and liver failure, all of which can be attributed to a chronic elevation in central venous pressure and a chronically reduced cardiac output. For all of these reasons, a 35 year-old patient who has gone through Fontan palliation has the approximate life expectancy of a 75 year old with normal cardiac physiology. Mezzion Pharma Co., Ltd. Forward-Looking Statements These and other risks and uncertainties are described more fully in Mezzion Pharma’s most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contact: Mr. S.I. Noh, Seoul, Korea, Tel: +82 2 560 8000
SOURCE Mezzion Pharma Co. Ltd. |
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