Mirum Announces Label Expansion for LIVMARLI in the United States to Include Infants Three Months of Age and Older
Mirum Pharmaceuticals today announced that the United States Food and Drug Administration (FDA) has approved a reduction in age from one year to three months for LIVMARLI (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). The label expansion was based on data from the RISE study which characterized the safety and tolerability of LIVMARLI in infants under one 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.”
LIVMARLI is currently approved for the treatment of cholestatic pruritus in patients with ALGS in the U.S. (three months and older) and in Europe (two months and older). Mirum has also submitted an sNDA in the United States for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.
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