FDA expands Livmarli label to include infants with pruritus aged 3 months or older
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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 2 RISE study, which assessed the safety and tolerability of maralixibat in infants aged less than 1 year with ALGS and progressive familial intrahepatic cholestasis.
“The vast majority of patients are diagnosed with ALGS before one year of age,” Chris Peetz, president and CEO at Mirum, said in the release. “The availability of Livmarli will offer an opportunity to introduce a treatment at the beginning of their ALGS journey with the goal of reducing serum bile acids and alleviating the unrelenting burden caused by pruritus. We are grateful to the patients and families who participated in the RISE study and made this important label expansion possible.”
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