New Delhi: The HIV drug Viread will now be available in powder form for HIV positive children after its approval by the US Food and Drug Administration (FDA), a bio-pharmaceutical company said Sunday. The move is expected to benefit millions of HIV positive children.
"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," Norbert Bischofberger, executive vice president, research and development and chief scientific officer at Gilead Sciences, said in a statement.
"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," Bischofberger added.
The FDA 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.
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. For adults unable to swallow Viread tablets, the oral powder formulation equal to 300 mg may be used.
According to the World Health Organization (WHO), 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.