Grandbrothers/iStock Editorial via Getty Images Mirum Pharmaceuticals ( NASDAQ: MIRM ) traded higher on Thursday after the rare disease drug developer announced that the FDA had approved a label expansion for its lead product, Livmarli, against a liver condition called progressive familial intrahepatic cholestasis (PFIC). The label expansion comes months after the FDA approved the once-daily oral therapy to treat cholestatic pruritus (itching due to liver disease) in PFIC patients aged five years and older. The latest decision expands its use for PFIC patients aged at least 12 months and includes approval for a higher-concentration formulation of Livmarli.
In 2021, Livmarli was approved by the FDA to treat cholestatic pruritus in patients with Alagille syndrome (ALGS), a genetically driven multisystem disorder. Japanese pharma giant Takeda ( TAK ) has partnered with Mirum ( MIRM ) to develop the oral solution for conditions including PFIC and ALGS in Japan. “The launch of LIVMARLI in PFIC is going well, and we are thrilled that it will now be available for patients 12 months and older,” said Mirum ( MIRM ) CEO Chris Peetz.
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