BridgeBio Pharma and Sentynl Therapeutics Receive EC’s Conditional Marketing Authorization for Nulibry (fosdenopterin) to Treat MoCD Type A
Shots:
- The EC has granted marketing authorization for Nulibry as 1st therapy for the treatment of MoCD Type A. The therapy will be available to qualified patients through an early access program
- The EC’s decision was based on the efficacy and safety data from the three clinical trials to evaluate the efficacy of Nulibry vs natural history study which showed that patients achieved a 7.1 times lower risk of death in the genotype-matched analysis with 86% vs 52% surviving @3yrs.
- The EC's centralized marketing authorization is valid in all EU member states, Iceland, Liechtenstein, & Norway. A regulatory filing to the MHRA is expected in the coming months as part of the EC decision reliance procedure
Ref: Globenewswire | Image: BridgeBio
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