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U.S. FDA Approves AbbVie's Hepatitis C Regimen for Priority Review

June 18, 2014

This article was reported by TechTimes.

TechTimes reported that the U.S. Food and Drug Administration (FDA) has granted priority review for Illinois-based drug manufacturer AbbVie's experimental all-oral regimen for treating adults infected with hepatitis C virus (HCV). The drug's application under priority review means that FDA must evaluate the safety and effectiveness of the AbbVie regimen within six months before letting the manufacturer know whether they may take the product to market. FDA first granted breakthrough therapy designation to the manufacturer's investigational treatment for chronic genotype 1 HCV in May 2013 when preliminary clinical evidence showed that the regimen led to better results than conventionally accepted treatments. AbbVie's new regimen consists of an antiviral called ritonavir and a protease inhibitor called ABT-450, combined with an NS5A inhibitor called ombitasvir and the polymerase inhibitor dasabuvir. When taken together, these mechanisms are powerful enough to stop HCV.

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