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Nulibry FDA Approval History

Last updated by Judith Stewart, BPharm on April 1, 2021.

FDA Approved: Yes (First approved February 26, 2021)
Brand name: Nulibry
Generic name: fosdenopterin
Dosage form: Injection
Company: BridgeBio Pharma, Inc.
Treatment for: Molybdenum Cofactor Deficiency (MoCD) Type A

Nulibry (fosdenopterin) is a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

  • MoCD Type A is an ultra-rare and progressive condition of infancy, with a median survival of four years. The most common symptoms are seizures, feeding difficulties and encephalopathy.
  • Nulibry is administered via intravenous infusion once daily.
  • Nulibry can cause photosensitivity reactions and patients should avoid or minimize exposure to sunlight and artificial UV light.
  • Common adverse reactions include catheter-related complications, pyrexia, viral infection, pneumonia, otitis media, vomiting, cough/sneezing, viral upper respiratory infection, gastroenteritis, bacteremia, and diarrhea.

Development timeline for Nulibry

Feb 28, 2021Approval FDA Approves Nulibry (fosdenopterin) to Reduce the Risk of Mortality in Patients with Molybdenum Cofactor Deficiency (MoCD) Type A
Sep 29, 2020BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A
Dec  3, 2019BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission Of New Drug Application With The U.S. FDA For BBP-870 For The Treatment Of MoCD Type A

Further information

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