Bylvay FDA Approval History
Last updated by Judith Stewart, BPharm on June 14, 2023.
FDA Approved: Yes (First approved July 20, 2021)
Brand name: Bylvay
Generic name: odevixibat
Dosage form: Capsules
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis, Cholestatic Pruritus in Alagille Syndrome
Bylvay (odevixibat) is an ileal bile acid transport (IBAT) inhibitor for the treatment of progressive familial intrahepatic cholestasis and cholestatic pruritus due to Alagille syndrome.
- Bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC) and for the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS). Bylvay may not be effective in PFIC2, a subtype of PFIC caused by mutations in the ABCB11 gene which causes deficiency of the Bile Salt Export Pump (BSEP) protein.
- Progressive familial intrahepatic cholestasis (PFIC) and cholestatic pruritus due to Alagille syndrome are conditions caused by genetic mutations that cause impaired bile flow. The subsequent toxic build-up of bile acids can lead to pruritus, which can be severe and debilatating.
- Bylvay contains odevixibat which is an ileal bile acid transport (IBAT) inhibitor. It works to treat cholestatic pruritus by inhibiting ileal bile acid transporter (IBAT) to decrease the reabsorption of bile acids from the terminal ileum in the small intestine.
- Bylvay capsules are administered orally once daily in the morning, with a meal.
- Warnings and precautions associated with Bylvay include liver test abnormalities, diarrhea, and deficiency of fat-soluble vitamins.
- Common adverse reactions in patients with PFIC include liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency.
Common adverse reactions in patients with ALGS include diarrhea, abdominal pain, hematoma, and decreased weight.
Development timeline for Bylvay
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