- The New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) and is based on results from the PEARL-I study, which demonstrated up to 100 percent sustained virologic response rates at 12 weeks post-treatment with no discontinuations due to adverse events - First all-oral, interferon-free therapy being evaluated by the FDA for patients with chronic genotype 4 (GT4) hepatitis C virus (HCV) infection - AbbVie's investigational regimen has been previously designated as a breakthrough therapy and received priority review by the FDA NORTH CHICAGO, Ill., April 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration...
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