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
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