FDA Accepts Albireo NDA for Liver Drug

FDA has accepted for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). Odevixibat is described as a potent, once-daily, non-systemic ileal bile acid transport inhibitor being developed to treat patients with rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. PFIC is a rare disorder that causes progressive, life-threatening liver disease, according to Albireo, adding that often PFIC leads to cirrhosis and liver failure within the first 10 years of life. The NDA is based on data from the PEDFIC 1 and PEDFIC 2 Phase 3 studies, which evaluated the efficacy and tolerability of odevixibat in reducing pruritus and serum bile acids in treated patients. The agency has set a 7/20 user fee review action goal date for the submission.