Latest From Genfit SA
Genfit believes elafibranor’s clean tolerability and safety profile may help narrow the gap between it and Intercept’s OCA, with safety questions delaying OCA’s entry to market. Part two of Scrip’s interview with Genfit’s CEO and COO.
As Genfit nears Phase III data for its NASH candidate elafibranor, it has promoted a new CEO and is working ahead on both an NDA filing and facing the commercial challenges of a new therapeutic space.
Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.
Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.
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