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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.

Development timeline for Bylvay

Jun 13, 2023Approval FDA Approves Bylvay for Patients Living with Cholestatic Pruritus Due to Alagille Syndrome
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

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