Albireo Seeks Approval for Odevixibat from FDA, EMA

Albireo has submitted applications with the FDA and the European Medicines Agency (EMA), seeking approval for odevixibat as a treatment for progressive familial intrahepatic cholestasis (PFIC), a rare disorder that causes progressive liver disease.

The once-daily drug is a nonsystemic ileal bile acid transport inhibitor and has received the FDA’s Fast Track, Rare Pediatric Disease and Orphan Drug designations. The EMA similarly gave it Accelerated Assessment and Orphan Drug designations and accepted it into its Priority Medicines program.

The company said the drug met both U.S. and EU primary endpoints in a phase 3 study, while long-term data from another late-stage trial also showed positive results. “These studies reaffirm odevixibat’s potential to be the first drug treatment approved for patients living with PFIC,” Albireo said.