Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved Viread® (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12. The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children ages 6-12. The agency also approved a New Drug Application (NDA) for an oral powder formulation of Viread for children ages 2-5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed molecule for adults receiving HIV therapy in the United States.
Viread was originally approved by the FDA in 2001 as a once-daily 300 mg tablet for individuals ages 18 and over for the treatment of HIV-1 infection in combination with other antiretrovirals. In March 2010, the 300 mg dose was approved for use in the United States among adolescents ages 12-17. In pediatric patients, the use of either the lower-strength tablets or the oral powder formulation of Viread is based on the patient's age and weight. The safety and efficacy of Viread has not been established in children less than two years of age. In HIV-infected adult patients, the dose is one 300 mg Viread tablet once daily taken orally, without regard to food. For adults unable to swallow Viread tablets, the oral powder formulation equal to 300 mg may be used.
The pediatric regulatory applications for Viread were supported by clinical data from a Phase 3 safety and efficacy study of a Viread-containing antiretroviral regimen compared to an antiretroviral regimen containing zidovudine or stavudine in HIV-infected treatment-experienced children ages 2-12. The safety profile observed in the study was consistent with that observed in clinical trials in adults. The applications were submitted to the FDA on July 18, 2011.
"Prenatal HIV testing and antiretroviral interventions during pregnancy have contributed to a dramatic decline in the number of children born with HIV in the United States. However, there remains an unmet need for heat-stable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where mother-to-child transmission remains a significant challenge," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "We are very pleased to provide an important new therapeutic option for younger HIV patients, and will work to make the pediatric formulations of Viread available as quickly as possible."