Mirum Pharmaceuticals (MIRM) Announces Extension of PDUFA Date for LIVMARLI to March 13, 2024

October 17, 2023 4:30 PM EDT

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the Supplemental New Drug Application (sNDA) for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The new Prescription Drug User Fee Act (PDUFA) date is March 13, 2024.

The FDA extended the PDUFA date to allow time for a full review of a submission provided in response to an FDA information request, which the FDA deemed a major amendment. The submission comprised further analysis of certain clinical information that was previously provided to the FDA by the company. No additional data or studies have been requested.

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