Zydus US arm gets EC authorisation or MoCD Injection

Zydus Lifesciences’ BridgeBio Pharma Inc., and Sentynl Therapeutics Inc., announced that the European Commission (EC) has granted marketing authorization for NULIBRY (fosdenopterin) for Injection as the first therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.MoCD Type A is an extremely uncommon and progressive illness that affects less than 150 individuals worldwide, with a four-year median survival.

NULIBRY is a first-in-class cPMP substrate replacement medication authorised by the US Food and Drug Administration (USFDA) in 2021 to lower the risk of mortality in MoCD Type A patients.

Following the EC’s decision, NULIBRY is the first and only authorised medication for MoCD Type A in the European Union (EU).Sentynl acquired the global rights to NULIBRY in March 2022 and is responsible for the continued development and marketing of NULIBRY in the United States, as well as the development, production, and commercialization of fosdenopterin globally.

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