Madrigal Pharmaceuticals Reports the EMA’s Validation for the MAA of Resmetirom to Treat NASH/MASH with Liver Fibrosis
Shots:
- The EMA has validated the company’s MAA of resmetirom to treat NASH/metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis and is currently under review
- The MAA was based on 18 clinical programs incl. twelve P-I trials, two P-II trials & four P-III trials. The P-III (MAESTRO-NASH) study of resmetirom for NASH was the trial to meet both the 1EPs of fibrosis reduction and NASH resolution
- Additionally, the NDA of the drug is under review with the US FDA and the decision is anticipated on March 14, 2024
Ref: Madrigal | Image: Madrigal
Related News:- Madrigal Pharmaceuticals Reports the Results of Resmetirom in P-III Trial for the Treatment of NASH Patients
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
