FDA grants label expansion for Livmarli to include infants three months of age and older for cholestatic pruritus with Alagille syndrome.- Mirum Pharma
Mirum Pharmaceuticals, Inc. announced that the 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). Additional information about Livmarlican be found on the product website, www.livmarli.com. Mirum has also submitted an sNDA in the United States for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.