By Samantha Bomkamp
9:12 a.m. CDT, May 6, 2013
AbbVie said Monday that its new hepatitis C drug regimen has been given a breakthrough therapy designation by the Food and Drug Administration, putting it on the fast track for potential approval in the United States.
A breakthrough therapy designation from the FDA is intended to expedite the development and review of drugs for serious or life-threatening conditions. It requires preliminary clinical proof that shows the drug may provide "substantial improvement" over therapies currently on the market.
AbbVie said the FDA's distinction stemmed from clinical trials involving patients infected with a particular strain of hepatitis C, an infectious disease that mostly affects the liver and that can ultimately lead to liver failure, cancer and other life-threatening complications. The trials showed high response rates to the combination therapy. It is currently in its third phase of clinical trials, involving more than 2,000 infected patients in 29 countries. The patients are treated for 12 to 24 weeks and will be followed for nearly a year after the treatment period ends.
There is no current vaccine for the disease. Hepatitis C is currently treated with a combination of antiviral medications. About 160 million people globally are chronically infected with hepatitis C.
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