11:20 AM EDT, 07/08/2024 (MT Newswires) -- Mirum Pharmaceuticals ( MIRM ) said Monday that the European Commission has approved the marketing of its oral treatment Livmarli for progressive familial intrahepatic cholestasis, or PFIC, in patients aged 3 months or more.
PFIC is a disorder that causes progressive liver disease.
The approval is based on a phase 3 study, which showed a significant reduction in pruritus and serum bile acids, as well as improvements in total bilirubin, the company said.
Mirum said it is seeking approval from the US Food and Drug Administration for a higher concentration formulation of Livmarli to extend its use to younger patients with PFIC.
Shares of the company rose nearly 5% in recent trading.
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