US FDA approves expanded use of Mirum’s liver disease drug

By Thomson Reuters Mar 13, 2024 | 5:49 PM

(Reuters) – The U.S Food and Drug Administration has approved the expanded use of Mirum Pharmaceuticals’ oral drug to treat itching caused by a liver disorder in patients aged five years and older, the company said on Wednesday.

The company’s shares rose 6% to $29.5 in extended trading.

The health regulator’s approval for the drug, branded as Livmarli, allows it to be used for treating itching caused by progressive familial intrahepatic cholestasis (PFIC), a genetic disorder that causes progressive liver disease typically leading to liver failure.

Livmarli is already approved for treating itching caused by another type of rare genetic liver disorder known as Alagille Syndrome (ALGS).

“The drug will be launched with immediate availability for eligible patients in the United States with the same pricing as it is for the approved ALGS indication,” Mirum Pharmaceuticals CEO Chris Peetz said ahead of the FDA decision.

The company said it has submitted an application to the FDA to expand the use of a higher concentration formulation of Livmarli in younger patients with PFIC.

(Reporting by Puyaan Singh, Pratik Jain and Mariam Sunny in Bengaluru; Editing by Shounak Dasgupta)