EMA expands patients population for bile disorder drug Livmarli

The European authorities have granted marketing authorization for Livmarli (maralixibat), for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients from the age of three months.

Developed by Mirum Pharmaceuticals (Nasdaq: MIRM), the product is backed by data from the Phase III MARCH study, the largest randomized trial conducted in PFIC.

Among other treatment benefits, data from the trial showed a statistically significant reduction in pruritus and serum bile acids between Livmarli and placebo, in the All-PFIC cohort.