Mirum's LIVMARLI Now Approved For Progressive Familial Intrahepatic Cholestasis In Patients 12 Months and Older
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Mirum Pharmaceuticals (NASDAQ:MIRM) received FDA approval for a label expansion of LIVMARLI® (maralixibat) oral solution, now approved for treating cholestatic pruritus in PFIC patients aged 12 months and older. The approval also includes a higher concentration formulation evaluated in the MARCH Phase 3 study.
July 25, 2024 | 12:33 pm
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Mirum Pharmaceuticals received FDA approval for an expanded label for LIVMARLI®, now approved for PFIC patients aged 12 months and older, including a higher concentration formulation.
The FDA approval for the expanded use of LIVMARLI® is a significant milestone for Mirum Pharmaceuticals. It opens up a larger market for the drug, potentially increasing sales and revenue. The inclusion of a higher concentration formulation also adds value to the product offering.
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