BridgeBio Pharma and affiliate Origin Biosciences announced the U.S. Food and Drug Administration has approved NULIBRY for Injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency Type A. This is the first therapy of its kind. The novel therapy was developed based on BridgeBio's commitment to developing a treatment for MoCD Type A in collaboration with the experts and families in the MoCD Type A community. MoCD Type A is an ultra-rare and progressive condition, known to impact less than 150 patients globally with a median survival of four years. MoCD Type A presents shortly after birth, often with severe encephalopathy and intractable seizures. NULIBRY is a first-in-class approved cPMP substrate replacement therapy. The efficacy of NULIBRY for the treatment of patients with MoCD Type A was established based on data from three clinical trials compared to data from a natural history study. In these studies, NULIBRY or recombinant cPMP reduced the risk of death by 82% compared to the untreated, genotype-matched, historical control group in the natural history study. At three years on study, the probability of survival in NULIBRY or rcPMP-treated patients was 84% compared to 55% for untreated genotype-matched patients in the historical control group at three years. In addition to the survival analysis, treatment with NULIBRY led to a reduction of urine concentrations of S-sulfocysteine, a toxic substance that leads to neurological damage, in patients with MoCD Type A, and the reduction was sustained with long-term treatment over 48 months. Animal studies have identified that NULIBRY has phototoxic potential. NULIBRY was reviewed under Priority Review and received Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA. With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher to Origin.

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