Posted by Michael Wonder on 29 Mar 2021
Mirum Pharmaceuticals announces FDA acceptance of new drug application and priority review for maralixibat in Alagille syndrome
29 March 2021 - PDUFA action date is 29 September 2021.
Mirum Pharmaceuticals announced today that its new drug application for maralixibat, an oral apical sodium dependent bile acid transporter inhibitor for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older, has been accepted for filing and priority review by the U.S. FDA.
