AbbVie files NDA for oral, interferon-free treatment of hepatitis C
US drugmaker AbbVie (NYSE: ABBV) has submitted its New Drug Application to the US Food and Drug Administration for approval of its 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, with six Phase III studies that included more than 2,300 patients in over 25 countries. The regimen is a combination of three antiviral agents: ABT-267, ABT-333 and ABT-450/ritonavir.
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