BridgeBio Pharma and Sentynl get EC authorization to market ‘NULIBRY'

21 Sep 2022 , 01:24 PM

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.

Sentynl and BridgeBio share development commitments through the clearance of NULIBRY’s regulatory submission with the Israeli Ministry of Health and the marketing authorization application under accelerated evaluation with the European Medicines Agency (EMA).

The EC approval comes on the heels of a positive opinion issued by the European Committee for Medicinal Products for Human Use (CHMP) in July 2022, which was supported by data from three clinical trials that demonstrated the efficacy of NULIBRY for the treatment of patients with MoCD Type A when compared to data from a natural history study.

At around 1.27 PM, Zydus Lifesciences was trading at Rs367.45 down by 0.89% from its previous closing of Rs370.75 on the BSE.

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