Zydus’ US arm gets EC authorisation for MoCD injection

AHMEDABAD: Homegrown pharma major, Zydus Lifesciences Limited’s wholly-owned subsidiary, US-based 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, Zydus said in its regulatory filing on Tuesday.
Nulibry was approved by the USFDA last year 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.
Earlier this year, Zydus’ US-arm acquired the global rights to Nulibry and is responsible for the ongoing development and commercialization of the injection in the US and developing, manufacturing, and commercializing Fosdenopterin globally.
“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.
“The approval of Nulibry by the European Commission is a promising development for children with MoCD Type A,” said Sharvil Patel, MD, Zydus Lifesciences, the parent company of Sentynl Therapeutics.
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.

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