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Mirum submits sNDA for Livmarli to treat cholestatic pruritus patients
The Fly

Mirum submits sNDA for Livmarli to treat cholestatic pruritus patients

Mirum Pharmaceuticals announced that it has submitted a supplemental New Drug Application, sNDA for LIVMARLI or maralixibat. oral solution for the treatment of cholestatic pruritus in patients two months of age and older with progressive familial intrahepatic cholestasis, PFIC… LIVMARLI is currently approved in the U.S. and Israel for the treatment of cholestatic pruritus in patients with Alagille syndrome, ALGS, one year of age and older, as well as in the European Union in the same indication, in patients two months of age and older. "Following the groundbreaking MARCH clinical data, we are thrilled at the opportunity to provide the PFIC community in the U.S. a treatment option that significantly reduces pruritus and gives hope for a life less burdened by PFIC," said Chris Peetz, president and chief executive officer at Mirum. "The MARCH PFIC study greatly advanced the understanding of treatment options for PFIC by including the broadest range of genetic types ever studied. We are working urgently to bring LIVMARLI to PFIC patients."

Published first on TheFly

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