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Medicine expected to be available immediately via prescription.
Ipsen, a biopharmaceutical organization, announced that the FDA has officially approved Bylvay, a treatment for cholestatic pruritus in patients aged one year and older with Alagille syndrome (ALGS). Initially approved as the first drug treatment for patients living with progressive familial intrahepatic cholestasis (PFIC), Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).
“Today’s approval of Bylvay in a second indication allows patients and physicians to access an additional treatment option that has the potential to improve the management of pruritus, or intense itch, in this distressing condition that tends to affect young children,” said Howard Mayer, EVP, head of research and development, Ipsen. “We are proud to have achieved FDA approval for Bylvay as a treatment for ALGS in the U.S. and we are committed to making it available to many more eligible patients across the world.”
Reference: U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome. Ipsen. June 13, 2023. Accessed June 20, 2023. https://www.ipsen.com/press-releases/u-s-fda-approves-bylvay-for-patients-living-with-cholestatic-pruritus-due-to-alagille-syndrome/