Mirum Pharmaceuticals, Inc. announced it has completed submission of its rolling New Drug Application to the U.S. Food and Drug Administration for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. ALGS is a rare liver disease for which there are currently no approved therapies. The company is planning for the U.S. launch of maralixibat in the second half of 2021, should the medication be approved by the FDA for this indication. The NDA submission included the results of the ICONIC study and additional supportive studies totaling 86 patients with ALGS with up to six-year follow-up. The clinical safety data submitted for maralixibat includes over 1,600 individuals treated. Until maralixibat is approved by the FDA for prescription, maralixibat is available to eligible patients with ALGS through Mirum’s Expanded Access Program (EAP). The EAP is available in the United States, Canada, Australia and in regions throughout Europe.