Zydus Lifesciences announced that its wholly-owned subsidiary Sentynl Therapeutics, Inc. (Sentynl), has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for NULIBRY? (fosdenopterin) for Injection as the first therapy for the treatment of patients in Great Britain (GB) with Molybdenum Cofactor Deficiency (MoCD) Type A. This is an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants. It is known to impact fewer than 150 patients globally with a median survival age of four year.
NULIBRY? is a first-in-class synthetic cPMP substrate replacement therapy that was approved by the U.S. Food and Drug Administration (FDA) in 2021 to reduce the risk of mortality in patients with MoCD Type A. Following this decision by the UK MHRA, NULIBRY? is the first and only approved therapy in GB for MoCD Type A.
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