Abbott’s lower strength Kaletra granted European approval

Kaletra is indicated for the treatment of HIV-1 infected adults and children above the age of two years. It is used in combination with other antiretroviral agents. The lower-strength Kaletra tablet offers HIV-positive children new benefits not available with the current soft capsules or oral solution, enhancing the dosing convenience without compromising efficacy. The Kaletra tablet can be taken with or without food and does not require refrigeration. Lopinavir or ritonavir is marketed as Aluvia in developing countries.

European Commission approval is significant for many developing countries because they require documentation of the marketing authorization to obtain a Certificate of Pharmaceutical Product (CPP) – often a prerequisite for regulatory filing in developing countries. In order to expedite review in developing countries, Abbott is working with regulatory agencies on a country-by-country basis to negotiate submissions before the CPP is available. Abbott intends to make the lower-strength tablet available or approved in 155 countries around the world, just as it has done with the adult tablet.

Carlo Giaquinto, Department of Pediatrics, University of Padua, Italy, chair of Pediatric European Network for Treatment of AIDS, said: “The lower-strength Kaletra formulation is the first and only co-formulated protease inhibitor tablet that can be used in children of appropriate age, weight or body surface area, representing a significant breakthrough for clinicians treating children with HIV in both developed and developing countries.”