Biotech Values

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AbbVie Submits New Drug Application to U.S. FDA for its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C

-Submission based on the largest Phase III program in genotype 1 (GT1) hepatitis C patients conducted to date
-AbbVie's investigational regimen was designated as a Breakthrough Therapy by the FDA
-AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May

NORTH CHICAGO, Ill., April 22, 2014 /PRNewswire/ -- AbbVie (ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The NDA is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date,1 with six Phase III studies that included more than 2,300 patients in over 25 countries.