Approvals cover use of oral powder formulation in patients aged 2-5 years.
FDA approved Gilead Sciences’ HIV therapy Viread® (tenofovir disoproxil fumarate), for use in combination with other antiretroviral agents in pediatric patients aged 2–12 years. FDA clearance relates to an NDA for an oral powder formulation of Viread for children aged 2–5 years, and a sNDA for once-daily Viread tablets in doses of 150 mg, 200 mg, and 250 mg, for children aged 6–12 years.
The approvals were based on data from a Phase III safety and efficacy study comparing a Viread-containing antiretroviral regimen, with either a zidovudine or stavudine-based antiretroviral regimen, in HIV-infected treatment-experienced children aged 2–12 years.
Gilead says it aims to make the pediatric formulations available as soon as possible. “Prenatal HIV testing and antiretroviral interventions during pregnancy have contributed to a dramatic decline in the number of children born with HIV in the U.S.,” comments Norbert Bischofberger, Ph.D., Gilead CSO and executive vp of R&D. “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.”
Viread was originally approved by FDA in 2001 as a once-daily treatment for HIV in adults over the age of 18 years. Approval was extended to adolescents aged 12–17 years in 2010. The drug is also approved in markets including the U.S. and Europe, as a treatment for chronic hepatitis B infection. Gilead reported sales of Viread reached $192.9 million for the third quarter of 2011 (to September 30), up 5% from $184.3 million in the third quarter of 2010.