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Non-Alcoholic Steatohepatitis-Related Cirrhosis

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The Emerging Role of Glucagon-Like Peptide-1 Receptor Agonists for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis

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June 23, 2023
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Intercept pivots away from NASH following second FDA rejection for obeticholic acid

  The FDA issued a complete response letter to Intercept indicating it cannot approve the company’s new drug application for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.

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June 15, 2023
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FDA grants fast track designation to Merck’s efinopegdutide for treatment of NASH

The FDA granted fast track designation to efinopegdutide for the treatment of nonalcoholic steatohepatitis, according to a manufacturer’s press release.

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May 23, 2023
2 min read
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Intercept ‘disappointed’ after FDA setback for top NASH contender; stock drops 16%

Intercept Pharmaceuticals saw a 16% drop in its stock value after an FDA advisory committee declined to approve obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis.

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December 09, 2022
4 min read
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NAFLD ‘not fit for purpose’: Experts debate impact of changing name vs. definition

WASHINGTON — The term ‘non-alcoholic fatty liver disease’ no longer reflects current knowledge of the disease and should be changed, members of the NAFLD Nomenclature steering committee noted during The Liver Meeting.

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November 08, 2022
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Efruxifermin induces NASH resolution, improves fibrosis by at least 1 stage vs. placebo

WASHINGTON — Efruxifermin improved liver histology, liver fat content and noninvasive markers of disease in patients with stage 2 or 3 fibrosis related to nonalcoholic steatohepatitis, according to late-breaking data at The Liver Meeting.

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October 05, 2022
3 min read
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Non-liver-related mortality can be higher in NAFLD ‘depending on age, fibrosis stage’

A patient outcomes simulator found that non-liver-related mortality could surpass liver-related mortality in patients with nonalcoholic fatty liver disease, depending on age and fibrosis stage at diagnosis, noted data in JAMA Network Open.

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May 27, 2022
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FDA grants fast track status to ervogastat plus clesacostat for NASH

The FDA has granted fast track designation to Pfizer for ervogastat in combination with clesacostat for treatment of patients with nonalcoholic steatohepatitis with liver fibrosis, according to a company press release.

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May 11, 2022
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Fatigue in patients with advanced NASH may increase risk for adverse events

Worse fatigue at baseline among patients with nonalcohol steatohepatitis-related advanced fibrosis and cirrhosis correlated with a higher risk adverse clinical events, according to published results.

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May 10, 2022
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Fibrotic NASH score may help health care providers predict at-risk patients

A noninvasive scoring system using routine laboratory data may help primary care providers screen for fibrotic nonalcoholic steatohepatitis and dysmetabolism in high-risk patients, according to a published study.

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