BridgeBio and Origin’s Nulibry (fosdenopterin) Receives the US FDA’s Approval as the First Therapy to Reduce the Risk of Mortality in Patients with MoCD Type A

March 1, 2021 Auto Bot approval, BridgeBio, FDA, mortality, patients, receives, regulatory, risk 0

Shots:

  • The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A
  • The results from three clinical trials showed improvement in overall survival and an 82% reduction in the risk of death, @3yrs. probability of survival in rcPMP-treated patients (84% vs 55%), reduction of urine concentrations of SSC and reduction was sustained with long-term treatment over 48mos., the high infant mortality rate
  • Nulibry is a first-in-class cPMP substrate replacement therapy and reviewed under PR and has received FDA’s ODD, BTD and RPDD. With this approval, the FDA also issued an RPD PRV to Origin

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PRNewswire

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