Zydus Lifesciences' Nulibry Receives EC’s Marketing Authorization for the Treatment of Molybdenum Cofactor Deficiency Type A
- The EC has granted marketing authorization for Nulibry to treat MoCD Type A. The EC decision was based on the efficacy & safety data of the Nulibry vs natural history study
- The EC’s centralized marketing authorization will be valid in all EU member states, Iceland, Liechtenstein, and Norway. The regulatory filing to the MHRA is expected in the coming months
- Nulibry is a cPMP substrate replacement therapy & was approved in the US in 2021 to reduce the risk of mortality in patients with MoCD Type A. In Mar 2022, Sentynl holds the global rights to Nulibry and is responsible for the ongoing development and commercialization in the US and also for developing, manufacturing, and commercializing fosdenopterin globally
Ref: Hindu | Image: Zydus Lifesciences
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