FDA accepts new drug application for pruritus treatment odevixibat
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The FDA accepted a new drug application for odevixibat for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis, according to a press release.
According to the manufacturer, Alibreo Pharma, the once-daily, non-systemic ileal bile acid transport inhibitor was granted priority review and set a goal date of July 20, 2021, for Prescription Drug User Fee Act approval.
“Odevixibat has the potential to become the first approved drug treatment for patients with [progressive familial intrahepatic cholestasis],” Ron Cooper, president and CEO of Albireo, said in the release. “Additionally, with no approved treatments, PFIC presents an exciting commercial opportunity and will pave the way for expected additional indications in Alagille syndrome and biliary atresia.”
Previous phase 3 studies found that the drug met primary endpoints in pruritus and serum bile acid. It was also well tolerated by patients.
In addition to progressive familial intrahepatic cholestasis, odevixibat is being developed as a treatment for biliary atresia and Alagille syndrome.
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