Posted by Michael Wonder on 06 Mar 2024
Madrigal Pharmaceuticals announces EMA validation of its marketing authorisation application for resmetirom for the treatment of NASH/MASH with liver fibrosis
5 March 2024 - MAA submission is supported by positive results from MAESTRO-NASH, the only Phase 3 trial in NASH to achieve fibrosis reduction and NASH resolution primary endpoints.
Madrigal Pharmaceuticals today announced that the Company’s marketing authorisation application for resmetirom for the treatment of NASH/metabolic dysfunction-associated steatohepatitis with liver fibrosis has been validated and is now under evaluation with the EMA's CHMP.
