Zydus Lifesciences arm application for Menkes disease treatment gets USFDA priority review
Solana Beach: Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd., and Fortress Biotech, Inc. has announced that the U.S. Food and Drug Administration (USFDA) has accepted for filing and Priority review Sentynl’s New Drug Application (NDA) for CUTX-101, the product candidate for the treatment of Menkes disease.
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A.
Recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 live male births. Sentynl’s NDA is supported by positive topline clinical efficacy results for CUTX-101, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment with CUTX-101, with a nearly 80% reduction in the risk of death compared to an untreated historical control cohort. Median overall survival was 177.1 months for CUTX-101 early treatment cohort compared to 16.1 months for the untreated historical control cohort.
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