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Lower Dose Lopinavir/Ritonavir Approved for Pediatric Use in Europe

ABBOTT PARK, Illinois, April 7 /PRNewswire/ -- Abbott announced today that it has received marketing authorization from the European Commission for the new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, Kaletra® (lopinavir/ritonavir). The Kaletra tablet can be taken with or without food and does not require refrigeration. Lopinavir/ritonavir is marketed as Aluvia® in developing countries.

European approval is a critical step in Abbott's 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. In Europe, there are approximately 4,000 children living with HIV.

Currently, the lower-strength tablet is available or approved in 53 countries in Europe, Africa, Asia, Latin America and in North America, and is filed in an additional 11 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.

"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, M.D., Department of Pediatrics, University of Padua, Italy, chair of PENTA (Pediatric European Network for Treatment of AIDS).

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.

-- Simple tablet form -- the lower-strength tablet is more convenient to administer than the oral solution.
-- Dosing is with or without food, providing patients greater flexibility -- the current soft capsule formulation should be taken with food.
-- No required refrigeration -- unlike the current soft capsule formulation or oral solution, which require refrigeration, the new Kaletra tablet can be stored at room temperature.

"HIV/AIDS continues to have a devastating effect on millions of children around the world, especially those patients living in resource-limited settings," said Scott Brun, M.D., divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "The new lower-strength Kaletra formulation is another example of Abbott's continued commitment to advancing treatment and care for the HIV community."

Kaletra Lower-Strength Tablet Availability
Based on the U.S. Food and Drug Administration (FDA) approval on Nov. 9, 2007, Abbott is shipping the lower-strength tablets to countries that have issued approved waiver orders. On Dec. 1, 2007, Uganda, the first country to issue such a waiver order, was one of the first countries in the world -- and the first country in Africa -- to receive the lower-strength tablets. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), an estimated 110,000 Ugandan children were living with HIV in 2005. Other African governments are now also talking to Abbott about the possibility of waiver shipments.

The World Health Organization recommends lopinavir/ritonavir as the preferred treatment for children who no longer respond to first-line HIV medicine. The U.S. Department of Health and Human Service recommends lopinavir/ritonavir for the initial treatment of children with HIV.

Kaletra Lower-Strength Tablets
The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its U.S. approval in September 2000. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility. The tablets contain 100mg of lopinavir and 25mg of ritonavir, compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir, most commonly used by adults.

The price of the lower-strength tablet will be half the price of the original-strength tablet everywhere it is available.

Source: Abbott

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