FDA expands Livmarli label to include infants with pruritus aged 3 months old or older

The FDA has approved labeling changes for Livmarli, reducing the age of prescribing to infants with Alagille syndrome from 1 year to 3 months for the treatment of cholestatic pruritus, according to a Mirum Pharmaceuticals press release.Maralixibat (Livmarli, Mirum Pharmaceuticals), a once-daily ileal bile acid transporter inhibitor, was originally approved by the FDA in 2021 for infants aged 1 year and older and remains the only FDA-approved medication for cholestatic pruritus associated with Alagille syndrome (ALGS).The FDA based its approval for the label expansion on data from the phase 2Read More