European regulators have followed in the footsteps of their counterparts across the Atlantic by giving the all clear to Abbott Laboratories’ lower-strength version of Kaletra for children with HIV.
The European Medicines Agency has given its seal of approval to the new lower-strength tablet formulation of Kaletra/Aluvia (100mg of lopinavir and 25mg of ritonavir, half the adult dose), which Abbott says is a “critical step” in its efforts to “expedite registration filings for the lower-strength tablet formulation in countries around the world, including in developing countries where more than 2 million of the estimated 2.3 million children worldwide with HIV/AIDS live”.
This is because the nod from the European Commission has wider implications than ‘merely’ allowing the drug to be sold in Europe, as it is also necessary for obtaining a Certificate of Pharmaceutical Product (CPP), which is often needed for regulatory filing in developing countries. Abbott says it has been working with countries on an individual basis to negotiate submissions before the CPP is available in order to speed up review times.
The oral formulation of Kaletra has been on the market since 2000, but according to Abbott the lower-strength pill will be of great benefit to children living with HIV worldwide, as it offers advantages of more convenient dosing “without compromising efficacy”, does not require refrigeration and can be taken with or without a meal, which the company stresses especially important in delivering such drugs to children in developing countries.
A ‘significant breakthrough’
“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,” said Carlo Giaquinto from the Department of Pediatrics, University of Padua, Italy, and chair of the Pediatric European Network for Treatment of AIDS, commenting on its approval.
Abbott says it intends to make the new version available globally as broadly as the already-approved tablet which, at 155 countries, will be one of the most, if not the most, widely registered HIV medicines in developing countries. The price of lower-strength tablet will be half the price of the full-strength one.
