IMPAACT 2007 Pharmacokinetic and Safety Data Informs U.S. FDA
The IMPAACT Operations Center has announced that IMPAACT 2007 data informed the FDA approval of 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.
The approval provides 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.”
From Frontier Science, the Protocol Data Managers were Barbara Heckman and Christina Reding, and the Laboratory Data Managers were Rachel Bowman and Kyle Whitson. Shawn Ward and Erica Gaughan were the SDTM specialists. Many from the IMPAACT SDAC made contributions to the success of the submission, including statisticians Kevin Butler and Pearl Samson, and programmers Victoria Wang and Jamie Branco. Kathryn Gray, Director of Biostatistics and Frontier Science Boston Office Director, oversaw the regulatory work at SDAC.