Lower-Strength Lopinavir/Ritonavir Tablet Approved in Europe for Paediatric Patients With HIV

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Title: Lower-Strength Lopinavir/Ritonavir Tablet Approved in Europe for Paediatric Patients With HIV
URL: http://www.pslgroup.com/dg/21F3AE.htm
Doctor's Guide
April 7, 2008

ABBOTT PARK, Ill. -- April 7, 2008 -- The European Commission has granted marketing authorisation for the new, lower-strength tablet formulation of the single-pill, combination protease inhibitor lopinavir/ritonavir (Kaletra). The tablet can be taken with or without food and does not require refrigeration. Lopinavir/ritonavir is marketed as Aluvia in developing countries.

Currently, the lower-strength tablet is available or approved in 53 countries in Europe, Africa, Asia, Latin America, and in North America. Abbott, the maker of lopinavir/ritonavir, has filed in an additional 11 countries. European Commission approval is significant for many developing countries because they require documentation of the marketing authorisation to obtain a Certificate of Pharmaceutical Product (CPP), often a prerequisite for regulatory filing in developing countries. 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 [lopinavir/ritonavir] formulation is the first and only coformulated 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, MD, Department of Pediatrics, University of Padua, Italy, and Chair, PENTA (Pediatric European Network for Treatment of AIDS).

The lower-strength lopinavir/ritonavir tablet offers HIV-positive children new benefits not available with the current soft capsules or oral solution, enhancing the dosing convenience without compromising efficacy:

· Tablet form

· Dosing with or without food (the current soft capsule formulation should be taken with food)

· No refrigeration required (can be stored at room temperature)

Based on the US Food and Drug Administration approval on November 9, 2007, Abbott is shipping the lower-strength tablets to countries that have issued approved waiver orders. On December 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 US Department of Health and Human Service recommends lopinavir/ritonavir for the initial treatment of children with HIV.

SOURCE: Abbott

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