FDA Approves Second New Treatment for Hepatitis C

On May 23, the U.S. Food and Drug Administration (FDA) announced the approval of telaprevir for the treatment of chronic viral hepatitis C. According to the U.S. Centers for Disease Control and Prevention, chronic viral hepatitis C affects 3.2 million Americans. Left untreated, chronic viral hepatitis C can lead to cirrhosis, liver cancer, and unwitting transmission to others.

The approval of telaprevir marks the second new treatment approved for chronic hepatitis C. On May 13, the FDA announced the approval of boceprevir. Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, calls the new treatments “a major step forward in the battle against chronic hepatitis C”, offering patients with this condition a greater chance at a cure.

In a major initiative to bring attention to combating viral hepatitis, the U.S. Department of Health and Human Services recently released the Action Plan for the Prevention, Care & Treatment of Viral Hepatitis (PDF 672KB). Among its goals, the Action Plan calls for a 25% reduction in the number of new cases of hepatitis C and an increase in the proportion of persons who are aware of their hepatitis C virus infection.

 

Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, U.S. Department of Health and Human Services

* Read the FDA’s full announcement on the approval of telaprevir.

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