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Podcast: Surfing the MASH Tsunami
Episode: S4-E22 - PART 1: FDA ADCOM Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis Due to NASH
Description: On Friday May 19, 2023, an Advisory Committee for the FDA convened to discuss the benefits and risks of obeticholic acid (OCA) 25 mg for treatment of non-alcoholic steatohepatitis (NASH) with fibrosis. As reported in a press release from Intercept Pharmaceuticals, twelve of 16 voting-eligible members of the ADCOM voted “no” (with two abstentions) on the voting question, “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” Fifteen of 16 voting-eligible members (with no abstentions) voted to “defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which t...