The US Food and Drug Administration (FDA) has approved Gilead Sciences, Inc.'s Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric 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 paediatric 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 paediatric 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 paediatric 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 paediatric formulations of Viread available as quickly as possible.”

According to the World Health Organization, there are approximately 2.5 million children under the age of 15 living with HIV worldwide, and more than 90 percent live in sub-Saharan Africa. In an effort to accelerate the availability of paediatric formulations in low-income countries, in July 2011, Gilead announced new incentives to encourage its Indian generic manufacturing partners to develop paediatric formulations of its HIV medicines.

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.