• FDA grants fast track status to ervogastat plus clesacostat for NASH

    1 month ago - By Healio

    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.
    Pfizer's investigational combination therapy targets key enzymes for the regulation of lipid metabolism, diacylglycerol O-acyltransferase 2 and acetyl-CoA carboxylase. Inhibiting these enzymes has previously been shown to lower liver fat in patients with nonalcoholic fatty liver disease, a benefit that Pfizer believes could be leveraged to improve inflammation and
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  • FDA grants priority review for Friedreich's ataxia treatment

    FDA grants priority review for Friedreich's ataxia treatment

    1 month ago - By Healio

    The FDA has granted priority review to Reata Pharmaceuticals Inc.'s new drug application for omaveloxolone to treat patients with Friedreich's ataxia.
    According to a company press release, the NDA is supported by positive safety and efficacy data from the MOXIe part 2 trial as well as supporting data from MOXIe part 1 and MOXIe extension trials.
    Omaveloxolone , an oral, once-daily anti-inflammatory therapeutic, received fast track designation in November 2021 and rare pediatric disease designation in May 2022. The priority review designation shortens the FDA's
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