The FDA has approved Gilead Sciences’ Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-I infection in pediatric patients ages 2 to 12.

Originally approved in 2001 for individuals aged 18+, and then again in 2010 for individuals ages 12 to 17, Viread is now approved for patients aged 2 to 12, with dosage based on age and weight. The safety and efficacy of Viread has not been established in children less than two years of age.

The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength, once-daily tablets of Viread in doses of 150mg, 200mg and 250mg for children ages 6 to 12. The agency also approved an NDA for an oral powder formulation of Viread for children ages 2 to 5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed molecule for adults receiving HIV therapy in the United States.

The pediatric regulatory applications for Viread were supported by clinical data from a phase III 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 to 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.

Although prenatal interventions have sharply decreased the number of U.S. children born with HIV, 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, Ph.D., executive vice president, R&D and chief scientific officer for 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.”

In an effort to accelerate the availability of pediatric formulations in low-income countries, in July 2011 Gilead announced new incentives to encourage its Indian generic manufacturing partners to develop pediatric formulations of its HIV medicines.