Posted by Michael Wonder on 02 Sep 2020
Mirum Pharmaceuticals initiates rolling submission of a new drug application for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome and launches expanded access program
1 September 2020 - Maralixibat would be the first treatment available for use in Alagille syndrome, if approved.
Mirum Pharmaceuticals today announced that it has submitted the first portion of its rolling new drug application to the U.S. FDA for maralixibat.
Maralixibat is a novel, minimally absorbed, orally administered apical sodium dependent bile acid transporter inhibitor being evaluated for the treatment of cholestatic pruritus in patients with Alagille syndrome. Mirum expects to complete the NDA submission in the first quarter of 2021.
