In this episode, Founder and CEO of the Global Liver Institute, Donna Cryer, joins Surfers Jörn Schattenberg and Roger Green for a session which draws from raw reflections on the FDA ADCOM meeting and its outcome for OCA.
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 time the traditional approval pathway could be considered.”
The reactions and discussion that unfold are both sobering and constructive as the group reckons with the unfavorable results and the way forward for the liver community. Critically, the group agrees on the idea that this event simply should not be dubbed “another NASH drug goes down.” Rather, the focus remains on the Committee message that goes, “If a drug under this definition of efficacy has a safety profile where we can trust doctors to be able to manage it, we’ll go with it because we understand the patient needs.” Listen on for the full analysis and stay tuned as Surfing NASH continues its coverage in subsequent episodes this week with different KOLs and stakeholders.
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