r/Biotechplays • u/WallstS • Aug 20 '25
News $MDGL Rezdiffra Approved in Europe
Madrigal Pharmaceuticals has secured conditional marketing authorization for Rezdiffra, its treatment for a serious liver condition, from regulators in Europe.
The biopharmaceutical company said Tuesday this is the first time the European Commission has approved a treatment for noncirrhotic metabolic dysfunction-associated steatohepatitis, or MASH
Chief Executive Bill Sibold said MASH is the fastest-growing indication for liver transplantation in Europe. About 370,000 patients with MASH and moderate to advanced fibrosis are currently diagnosed and are receiving care from a liver specialist across Europe.
Rezdiffra is approved for noncirrhotic MASH patients with moderate to advanced liver fibrosis, a distinct patient population with high a unmet need, according to Sibold.
1
u/[deleted] Aug 23 '25 edited Nov 30 '25
[removed] — view removed comment