U.S. FDA approves new indications for Harvoni and Sovaldi in pediatric patients 12 years and older with chronic hepatitis C infection.

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.

Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth.

“The approvals of Sovaldi and Harvoni for pediatric patients will enable adolescents to finally benefit from interferon-free treatment for HCV infection,” said Karen Murray, M.D., professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s. “These therapies address a significant unmet medical need and represent an important advance for HCV-infected adolescents.”

“Gilead’s goal is to develop and deliver treatments that provide all patients with HCV the potential to be cured,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic HCV infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections.”

Harvoni and Sovaldi each have a boxed warning in their respective product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients.

(Source: Business Wire)