Genfit Hopes To Make Case For First-Line Treatment In NASH
French company expects Phase III data later in 2019 that will demonstrate elafibranor’s ability to resolve NASH without worsening of fibrosis. Genfit also is partnered with Covance on a potential diagnostic test for NASH.
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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.
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.