FDA approves Bylvay for treating progressive familial intrahepatic cholestasis
Albiero Pharma Inc. announced it received FDA approval for Bylvay to treat pruritus in all subtypes of progressive familial intrahepatic cholestasis.
According to a press release, it is the first drug approved for PFIC.
Bylvay (odevixibat) is a non-systemic ileal bile acid transport inhibitor. Odevixibat will not require refrigeration and is administered as a once-daily capsule or can be opened and sprinkled onto soft foods.
The company will launch the treatment immediately.
“Bylvay is the first ever approval by the FDA of a drug developed for a pediatric cholestatic liver disease and provides a non-surgical treatment for patients living with the burden of PFIC,” Ron Cooper, president and CEO of Albireo, said in the release. “We’re humbled by the children, families and investigators whose commitment to our clinical trials will bring hope and treatment benefit for so many future patients.”
According to the release, the approval was supported by data from the PEDFIC 1 and PEDFIC 2 phase 3 trials. In both studies, odevixibat was well tolerated. The most common adverse events included diarrhea/frequent stools, with no serious adverse events reported.