Madrigal Pharmaceuticals announced that resmetirom has received Breakthrough Therapy designation, BTD, from the U.S. Food and Drug Administration for the treatment of patients with NASH with liver fibrosis. The Company also announced that the outcomes portion of the Phase 3 MAESTRO-NASH biopsy trial has completed enrollment. Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, "The Breakthrough Therapy designation for resmetirom reflects the FDA’s recognition of resmetirom’s potential in the treatment of NASH as a serious, life-threatening condition and an important area of investigational drug development. It also reinforces our confidence in our regulatory strategy as we approach the new drug application (NDA) filing for resmetirom, which remains on track for Q2 2023. The filing is supported by the positive outcomes on reduction of liver fibrosis and resolution of NASH from the 52-week serial liver biopsy portion of MAESTRO-NASH."
Published first on TheFly
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