Mirum Pharmaceuticals Gets Additional FDA Approval for Livmarli
By Sabela Ojea
Mirum Pharmaceuticals said the Food and Drug Administration approved Livmarli to treat cholestatic pruritus, a feeling of itchness, in patients five years of age and older with progressive familial intrahepatic cholestasis.
The pharmaceutical company on Wednesday said that the latest approval is based on data from the March Phase 3 study.
Livmarli is also approved to treat cholestatic pruritus in patients with Alagille syndrome in the U.S., Europe, Canada and other regions.
The company has also submitted an additional supplemental new drug application to introduce a higher concentration of the oral solution to enable label expansion for younger patients with the disease later this year.
Progressive familial intrahepatic cholestasis is a medical term that includes a group of rare genetic disorders that cause a progressive liver disease.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
March 13, 2024 18:36 ET (22:36 GMT)
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