Harvoni, Sovaldi approved for pediatric patients

The Food and Drug Administration on April 7 approved Sovaldi and Harvoni to treat the hepatitis C virus in patients ages 12 to 17.

The drugs, developed by Gilead Sciences, represent the first direct-acting antiviral treatments approved for this patient population.

Harvoni and Sovaldi can treat six major strains of hepatitis C and work by preventing the virus from multiplying.

"These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. 

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