FDA accepts listing application for oberic acid treatment for non-alcoholic fatty hepatitis
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Intercept announcedThe FDA(http://has accepted a market ingressation application for the treatment of non-alcoholic fatty hepatitis (NASH) for liver fibrosis and has been qualified for priority reviewIntercept submissions were based primarily on data from key randomized, double-blind, placebo-controlled, Phase III REGENERATE studiesThe results showed that at the 18th month of the OCA 25mg daily treatment group, the proportion of patients with at least 1 grade of liver fibrosis and no deterioration of NASH was significantly higher than in the placebo group (21% vs 10.6%)At the 18th month of the OCA 10mg and 25mg treatment group, the proportion of patients with improved histopathological lynosology (reduced fat build-up) and no deterioration in fibrosis was higher than in the placebo group, but there was no statistically significant differenceObercacid, a fanieste X receptor agonist, was approved by the FDA in May 2016 to treat primary bile cirrhosis (PBC), an indication that was also approved by the European Union in December 2016Ocaliva's 2019H1 global sales revenue was $118 million, up 50.1% year-on-year
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