FDA label expansion makes maralixibat available for infants 3 months and older with ALGS

The U.S. Food and Drug Administration approved a reduction in age from 1 year to 3 months for maralixibat (Livmarli; Mirum) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS), according to a press release.

The label expansion was based on data from the RISE study which characterized the safety and tolerability of LIVMARLI in infants under 1 year of age with ALGS.

“The vast majority of patients are diagnosed with ALGS before one year of age. 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,” commented Chris Peetz, president and chief executive officer at Mirum. “We are grateful to the patients and families who participated in the RISE study and made this important label expansion possible.”

Read the full press release here.

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