Mirum Pharmaceuticals, Inc. announced that its New Drug Application (NDA) for maralixibat, an oral apical sodium dependent bile acid transporter (ASBT) inhibitor for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older, has been accepted for filing and priority review by the U.S. Food and Drug Administration (FDA). ALGS is a rare liver disease for which there are currently no approved therapies. Mirum completed the rolling NDA submission in January 2021 and the Prescription Drug User Fee Act (PDUFA) date, or FDA decision date, is September 29, 2021. Priority review is granted by the FDA for potential drugs that, if approved, would provide significant improvements in the effectiveness and safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA is not currently planning to hold an advisory committee.