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Bylvay FDA Approval History

Last updated by Judith Stewart, BPharm on July 20, 2021.

FDA Approved: Yes (First approved July 20, 2021)
Brand name: Bylvay
Generic name: odevixibat
Dosage form: Capsules
Company: Albireo Pharma, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis (PFIC)

Bylvay (odevixibat) is an ileal bile acid transport (IBAT) inhibitor for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

  • Patients with progressive familial intrahepatic cholestasis have genetic mutations that cause impaired bile flow, which can result in bile build-up in liver cells and subsequent intense itching. Bylvay works by inhibiting ileal bile acid transporter (IBAT) to decrease the reabsorption of bile acids from the terminal ileum in the small intestine.
  • Bylvay may not be effective in PFIC2, a subtype of PFIC with mutations in the ABCB11 gene which causes deficiency of the Bile Salt Export Pump (BSEP) protein.
  • Bylvay capsules are administered orally once daily in the morning, with a meal.
  • Common adverse reactions include liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency.

Development timeline for Bylvay

Jul 20, 2021Approval FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)
Jan 25, 2021Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat
Dec  8, 2020Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC
Jul 14, 2020Albireo Enrolls First Patient in Phase 3 Clinical Trial of Odevixibat in Biliary Atresia

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.