Abbott Statement
Update to Abbott's Statement on the Filing in Thailand of the Lower-strength Kaletra/Aluvia® Tablet Suitable for Pediatric Use
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November 14, 2007 — Abbott submitted its registration application in Thailand for the lower-strength tablet formulation of Aluvia® (lopinavir/ritonavir), suitable for pediatric use, and is awaiting a decision from the Thai Food and Drug Administration. The new lower-strength tablets of Kaletra and Aluvia are a significant development for patients living with HIV. The tablets do not require refrigeration and can be taken with or without a meal – an important advance in delivering HIV medicine to children in developing countries.
The new tablet formulation contains 100 mg of lopinavir and 25 mg of ritonavir and will complement currently available Kaletra capsules and oral solution, which have been approved and marketed in Thailand since August 2001. Abbott continues to supply these formulations for the benefit of Thai patients.
Abbott is awaiting EMEA marketing authorization for the Kaletra/Aluvia lower-strength tablets. Upon EMEA marketing authorization, Abbott intends to register this new tablet formulation in more than 150 countries. Abbott is working with governments around the world to expedite registration of the lower-strength Kaletra/Aluvia tablet, wherever possible.
Abbott's Commitment to Fighting HIV/AIDS
HIV/AIDS is a global problem that demands shared commitment and shared responsibility. Abbott is committed to working with governments, multilateral organizations, nongovernmental organizations (NGOs) and civil society to expand access to HIV/AIDS treatments around the world.
Through its Access program, Abbott provides its HIV medicines at no-profit pricing in many developing countries. Since April 2007, Abbott has offered its HIV medicines in two pricing tiers across 115 low- and lower-middle-income countries.1 In addition, Abbott has consistently made its medicines available at a price below that of any generic competitor in each of the pricing tiers.2
Abbott and the Abbott Fund are investing more than $100 million in developing countries through the Abbott Global AIDS Care programs focusing on four areas: strengthening health care systems; helping children affected by HIV/AIDS; preventing mother-to-child transmission of HIV; and expanding access to testing and treatment.
According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2006, an estimated 2.3 million children under the age of 15 were living with HIV/AIDS worldwide. Last year alone, an estimated 530,000 children were infected with HIV, and 380,000 children died of AIDS.3 The World Health Organization recommends lopinavir/ritonavir as one of three protease inhibitor (PI) options for the treatment of children who no longer respond to first-line HIV medicines.4 The U.S. Department of Health and Human Services recommends lopinavir/ritonavir for the initial treatment of children with HIV.
For more information about our commitment to fighting HIV/AIDS, please visit our Web site at www.abbott.com/hiv.
