Zydus Lifesciences' US-based subsidiary, Sentynl Therapeutics along with BridgeBio Pharma received a marketing authorisation from the European Commission (EC) to market Nulibry (Fosdenopterin) injection.
The injection is used to treat patients with an ultra-rare and progressive condition, molybdenum cofactor deficiency (MoCD) Type-A.Nulibry is a 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 EC, it is the first and only approved therapy in the European Union (EU) for MoCD Type A.
In March 2022, Sentynl acquired the global rights to Nulibry and is responsible for the ongoing development and commercialization of the injection in the United States and developing, manufacturing, and commercializing Fosdenopterin globally.
Sentynl and BridgeBio share development responsibilities through the approval of the marketing authorization application under accelerated assessment with the European Medicines Agency (EMA) and through approval of Nulibry's regulatory submission with the Israeli Ministry of Health.
The European Commission's approval of Nulibry is an exciting step in delivering this therapy to all children suffering with MoCD Type A worldwide, said BridgeBio founder and CEO Neil Kumar.
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Dr. Sharvil Patel, managing director of Zydus Lifesciences, the parent company of Sentynl Therapeutics said, The approval of Nulibry by the European Commission is a promising development for children with MoCD Type A. Zydus Group is committed to making a meaningful difference in the lives of people suffering from rare and orphan diseases.
Matt Heck, CEO of Sentynl said, This is a major milestone for those patients living with MoCD Type A in Europe. Marketing authorization is an important step in providing access to Nulibry and creating awareness of MoCD Type A as many patients are often missed.
The EC's centralized marketing authorization is valid in all EU member states as well as Iceland, Liechtenstein, and Norway. A regulatory filing is expected in the coming months to the UK's Medicine and Healthcare products Regulatory Agency (MHRA) as part of EC's decision reliance procedure.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.
The scrip shed 1.07% to currently trade at Rs 366.80 on the BSE.
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