The FDA on June 13 approved Ipsen’s Bylvay (odevixibat) for the treatment of cholestatic pruritus due to Alagille syndrome, a rare genetic disorder that can cause liver damage, in patients 12 months of age and older. Ipsen bought the ileal bile acid transport inhibitor (IBATi) when it acquired Albireo Pharma, a biotech focused on rare diseases, for $925 million earlier this year. The once-daily therapy was first approved in 2021 for the treatment of cholestatic pruritus from progressive familial intrahepatic cholestasis, another pediatric liver disorder. It currently holds covered or better status for 75% of all insured lives under the pharmacy benefit, largely with utilization management restrictions applied.
SOURCE: MMIT Analytics, as of 6/14/23