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Ipsen’s Bylvay (odevixibat) Receives the US FDA’s Approval for the Treatment of Cholestatic Pruritus Due to Alagille Syndrome

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Ipsen’s Bylvay (odevixibat) Receives the US FDA’s Approval for the Treatment of Cholestatic Pruritus Due to Alagille Syndrome

Shots:

  • The US FDA has approved Bylvay, a non-systemic ileal bile acid transport inhibitor for patients with cholestatic pruritus aged 12mos. with ALGS
  • The approval was based on the P-III study (ASSERT) evaluating odevixibat (120µg/kg/day) for 24wks. in patients aged 0-17yrs. The study met 1EPs & showed an improvement in pruritus, ≥90% were pruritus responders (≥1 point change at any time during 24wks.), the overall incidence of TEAEs was similar to PBO & no patients discontinued the study, 96% rolled over into the OLE study
  • Bylvay was approved in the US for pruritus in patients aged ≥3mos. with PFIC & also approved in the EU for PFIC in patients aged ≥6mos. Bylvay is immediately available via prescription for eligible ALGS patients

Ref: Ipsen | Image: Ipsen

Related News:- Albireo Report Enrollment Completion in P-III (ASSERT) Study of Bylvay (odevixibat) for the Treatment of Alagille Syndrome

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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