FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.
Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.
"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," Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. "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."