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
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