Ipsen’s Bylvay approved by FDA for severe itching due to Alagille syndrome

Bylvay approved by FDA for severe itching due to Alagille syndrome

Ipsen’s Bylvay (odevixibat) has been approved by the US Food and Drug Administration (FDA) to treat cholestatic pruritus (intense itching) in patients aged 12 months and older with Alagille syndrome (ALGS).

The approval marks the second rare disease indication for Bylvay in the US, after the drug was approved in 2021 to treat cholestatic pruritus from progressive familial intrahepatic cholestasis.

ALGS is an inherited rare, genetic disorder that can affect multiple organ systems in the body, including the liver, heart, skeleton, eyes and kidneys.

Liver damage results from having fewer than normal, narrowed or malformed bile ducts, which leads to toxic bile acid build-up.

Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first few months of life, and as many as 88% also present with severe pruritus.