FDA approval of REZDIFFRA (resmetirom) for NASH/MASH treatment

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This video describes the approval of REZDIFFRA, which contains resmetirom as its active pharmaceutical ingredient. REZDIFFRA is approved for treatment of liver fibrosis due to NASH (non-alcoholic steatohepatits) or MASH (metabolic dysfunction-associated steatohepatits). REZDIFFRA was approved by the U.S. FDA on March 14, 2024. The sponsor of the NDA was Madrigal Pharmaceuticals. Resmetirom's mechanism of action is as a thyroid receptor-beta agonist with selectivity for the beta receptor over the alpha form. Efficacy, ADME/PK, and key safety risks of REZDIFFRA are discussed.

This video was created for academic purposes. The creator of the video has no financial stake in the drug sponsors or relationship with the FDA.