Published on 15 Mar 2024 on Zacks via Yahoo Finance
Mirum Pharmaceuticals, Inc. MIRM announced that the FDA had approved a label expansion for Livmarli (maralixibat) oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC). Livmarli is an orally administered ileal bile acid transporter inhibitor.
It is important to note that Livmarli is already approved in the United States and EU as the only medication for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged three months and older and two months and older, respectively. Mirum’s Livmarli is also currently approved in other geographies worldwide to treat the ALGS indication.
A regulatory filing seeking label expansion for Livmarli in the EU for patients aged two months and older with PFIC is currently under review.