EC Endorses Pediatric Formulation Of Abbott's Antiretroviral Kaletra

Armen Hareyan's picture

A Europeanregulatory advisory committee recently recommended approval of a pediatricformulation of Abbott Laboratories' antiretroviral drug Kaletra, the Chicago Tribune reports (Japsen, ChicagoTribune, 1/30). The EuropeanCommittee for Medicinal Products for Human Use, a committee of the European Medicines Agency, in coordination with the World Health Organization also recommended the approval of a pediatric version of Aluvia, thetrade name of Kaletra in developing countries (Abbott release, 1/28). CHMP'srecommendation means that the pediatric formulation of Kaletra, which is abouthalf the strength of the adult version, could be available in Europein 60 to 90 days.

In addition, European approval of the drug could help improve treatment accessamong children in developing countries because official approval in Europe often leads to regulatory approval in developingnations, the Tribune reports. Lower-strength doses also do notrequire refrigeration and can be taken "with or without a meal,"according to an Abbott spokesperson (Chicago Tribune, 1/30).Abbott has said that it is working with regulatory bodies on a"country-by-country basis" to speed evaluation of the drug'spediatric formulation in developing countries. The price of the pediatric dosewill be half the price of the original-strength version everywhere it isavailable (Abbott release, 1/28).

Reprintedwith permission from You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, and sign upfor email delivery at . The Kaiser Daily HIV/AIDS Reportis published for, a free service of The Henry J. KaiserFamily Foundation.