Madrigal Pharmaceuticals Announces EMA Validation of its Marketing Authorization Application for Resmetirom for the Treatment of NASH/MASH with Liver Fibrosis
NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.
- NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.
- Resmetirom is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH.
- The clinical development program for resmetirom is comprised of 18 clinical studies supporting the MAA: twelve Phase 1 studies, two Phase 2 studies, and four Phase 3 studies.
- Without treatment, the disease can lead to cirrhosis, liver failure, liver cancer and premature death,” said Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal.