05:08 AM EDT, 03/14/2024 (MT Newswires) -- Mirum Pharmaceuticals ( MIRM ) said late Wednesday the US Food and Drug Administration has approved its Livmarli product for the treatment of cholestatic pruritus in patients who are at least five years old with progressive familial intrahepatic cholestasis.

Progressive familial intrahepatic cholestasis is a genetic disorder that leads to progressive liver disease, typically causing liver failure.

Mirum also said it has submitted a supplemental new drug application to introduce a higher concentration of Livmarli to enable label expansion for younger patients.

The approval was based on data from a phase 3 study with 93 patients across a range of genetic progressive familial intrahepatic cholestasis types, the company said.