May 7th, 2013
A new anti-viral combination for hepatitis C has been given a breakthrough therapy designation by the Food and Drug Administration (FDA), putting it on the fast track for potential approval in the United States.
The treatment, developed by the biopharmaceutical company AbbVie, is a direct-acting antiviral that combines three different components, each with a separate mechanism for addressing the disease. 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 almost a year after the treatment period ends.
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.