预约演示
FDA approves Mirum’s LIVMARLI for cholestatic pruritus
上市批准孤儿药临床结果临床3期并购
Mirum Pharmaceuticals’s LIVMARLI (maralixibat) oral solution is now available in the US for cholestatic pruritus in patients with PFIC. Credit: Mirum Pharmaceuticals / Business Wire.
Mirum PharmaceuticalsAdministration (FDA) has approved Mirum Pharmaceuticals’s LIVMARLI (marcholestatic pruritusion to treat cholePFICic prurituMirum Pharmaceuticals
The medFood and Drug Administration (FDA)ged five yearsMirum PharmaceuticalsessLIVMARLIlimaralixibatatic cholestasis (PFIC).cholestatic pruritus
A once-daily, orally administered ileal bile acid transporter inhibitorprogressive familial intrahepatic cholestasis (PFIC)IC.
The approval is based on findings ileal bile acid transporterinical trialLIVMARLIFIC patients.PFIC
The randomised trial enrolled people with PFIC genetic types PFIC1, PFIC2, PFIC3, PFIC4 and PFIC6, along with people with unidentified mutational status.
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The FDA, the European Commission and Health Canada have also granted approval for LIVMARLI for the treatment of cholestatic pruritus in patients with Alagille syndrome in their respective regions.
FDAaddition to itsMapi Pharmaprovals, Mirum has fileRMS supplemental new drug application to the FDA. The aim is to introduce a higher concentration formulation of LIVMARLI, which was utilised in the Phase III MARCH study.
This could expand the treatment’s label for younger PFIC patients later in 2024.
A raFDAgenetic disorder, PFIC resultsHealth Canadave liver disease that can go on LIVMARLI liver failure.cholestatic pruritusAlagille syndromeAlagille syndrome
“Thank you to the patients, families and clinicians whose study participation made this approval possible.”
In September 2023, the coPFICy concluded progressive liver diseasele acid product portfolioliver failureherapeutics.
Mirum Pharmaceuticalsts and assets related to CLIVMARLIcholic acid) and Chenodal (chenodiol).cholestatic pruritusPFIC
Travere secured $210m from Mirum, with the potential to receive $235m in sales-based milestone payments.
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