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Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH
12 of 16 voting-eligible advisors vote “no” (with two abstentions) on 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?” 15 of 16 voting-eligible advisors vote to “defer approval until clinical outcome data from trial 747-303 are […] The post Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH appeared first on Fo... Read More
Posted: May 19 2023, 22:45
Author Name: forextv
Views: 102140

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