MIRM - FDA Approves Mirum's Livmarli For Liver Disease In Kids As Young As 5 Years: Analyst Bullish On Label Expansion Strategy | Benzinga
Wednesday, The FDA approved Mirum Pharmaceuticals Inc’s (NASDAQ:MIRM) Livmarli (maralixibat) oral solution for cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC).
In people with PFIC, liver cells are less able to secrete bile, and the buildup of bile in liver cells causes liver disease.
The approval is based on data from the Phase 3 MARCH study, the largest randomized trial conducted in PFIC, with 93 patients across various genetic PFIC types.
Mirum has also submitted an additional supplemental new drug application to introduce a higher concentration formulation of Livmarli, used during the MARCH study, to enable label expansion for younger patients with PFIC later this year.
HC Wainwright rights after discussion with management, the company ...