Will we see the world's first approved NASH drug in 2020?

| December 20, 2019

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Nonalcoholic steatohepatitis (NASH) has been among the closely watched indications in biotech since January 2014, when Intercept Pharmaceuticals lit a fire under the field with midphase data that sent its share price up 500%. Now, Intercept is on the cusp of delivering on the promise that caused investors to pile into the stock. On April 22, an advisory committee is set to assess the merits of the data on obeticholic acid (OCA), teeing the FDA up to decide whether to make Intercept’s drug the first treatment approved in NASH. Genfit’s elafibranor is following close behind, with phase 3 results scheduled for the first quarter of 2020. If the FDA authorizes either drug, it will mark the start of a new phase in the intense scrap for the blockbuster NASH market.

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