European Advisory Committee Endorses Pediatric Formulation Of Abbott's Antiretroviral Kaletra

Main Category: HIV / AIDS
Also Included In: Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 04 Feb 2008 - 6:00 PDT

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A European regulatory advisory committee recently recommended approval of a pediatric formulation of Abbott Laboratories' antiretroviral drug Kaletra, the Chicago Tribune reports (Japsen, Chicago Tribune, 1/30). The European Committee 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, the trade name of Kaletra in developing countries (Abbott release, 1/28). CHMP's recommendation means that the pediatric formulation of Kaletra, which is about half the strength of the adult version, could be available in Europe in 60 to 90 days.

In addition, European approval of the drug could help improve treatment access among children in developing countries because official approval in Europe often leads to regulatory approval in developing nations, the Tribune reports. Lower-strength doses also do not require 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's pediatric formulation in developing countries. The price of the pediatric dose will be half the price of the original-strength version everywhere it is available (Abbott release, 1/28).

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