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AbbVies hep C regimen granted breakthrough therapy designation
June 2013
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NORTH CHICAGO, Ill.The U.S. Food and Drug Administration (FDA) has granted a breakthrough therapy designation to AbbVie's new hepatitis C drug regimen, speeding it toward approval in the United States. The FDA's breakthrough therapy designation is meant to accelerate the development and review of drugs for serious or life-threatening conditions, and is only granted to therapies that can provide preliminary clinical proof that the drugs may provide "substantial improvement" over existing treatments. AbbVie's treatment is an investigational direct-acting antiviral combination with and without ribavirin for the treatment of genotype 1 hepatitis C virus infection. In a Phase IIb trial, the regimen "provided high sustained viral response rates," AbbVie noted in a press release, in both treatment-nave patients and null responders. The drug regimen is now in its third phase of clinical trials.  

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