US FDA approves expanded use of Mirum's liver disease drug (updated)

Mirum Pharmaceuticals

13/03/2024 22:30

(Adds shares, background and CEO comment in paragraphs 2-6)
       March 13 (Reuters) - The U.S Food and Drug
Administration has approved the expanded use of Mirum
Pharmaceuticals'  MIRM.O  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)
 ((Mariam.ESunny@thomsonreuters.com))