IMPAACT 2007 informs U.S. FDA approval of two supplements, expanding the Selzentry label.

5 November 2020

On 30 October 2020 the U.S. FDA approved two supplements for Selzentry (Maraviroc) Tablets and Oral Solution, which expanded the Selzentry label to include dosing for individuals less than two years of age and weighing at least 2 kg, thus providing approved labeling for all age groups receiving non-interacting concomitant medications for this product. The supplements consisted of new pharmacokinetic and safety data from IMPAACT 2007 in neonates (birth to six weeks of age) born to mothers living with HIV-infection as well as modeling and simulation data to bridge the age groups and provide dosing for pediatric patients aged > 6 weeks to < 2 years. The approved indication is “SELZENTRY is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg.”

 

 

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.