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# Ipsen’s Bylvay Gets Expanded Use
- URL: https://www.fdaweb.com/ipsens-bylvay-gets-expanded-use/
- Published: 2023-06-13T12:00:00.000Z
- Updated: 2026-09-14T18:38:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154684

FDA has approved Ipsen’s Bylvay (odevixibat) for an expanded use — treating cholestatic pruritus in patients aged 12 months and older with Alagille syndrome (ALGS). The once-daily, non-systemic ileal bile acid transport inhibitor acts locally in the small intestine and has minimal systemic exposure, according to the company. It was first approved in 2021 for patients living with cholestatic pruritus due to progressive familial intrahepatic cholestasis.

ALGS is described as an inherited rare, genetic disorder that can affect multiple organ systems in the body including the liver, heart, skeleton, eyes and kidneys. “Liver damage may result from having fewer than normal, narrowed or malformed bile ducts, which leads to toxic bile acid build-up, which in turn can cause scarring and progressive liver disease,” the company says.

The approval was based on data from the Phase 3 ASSERT study that demonstrated Bylvay provided “highly statistically significant and clinically meaningful sustained improvements in pruritus, starting early after initiation of treatment,” Ipsen says. “The overall incidence of treatment-emergent adverse events was similar to placebo. No patients discontinued the study and 96% of patients rolled over into the open-label extension study.”