New Abbott Aluvia® Tablet for Treatment of HIV Available in South Africa
More than 5 Million South Africans Living with HIV Gain Access to First and Only Co-formulated, Non-refrigerated Protease Inhibitor
Abbott ( NYSE: ABT) today announced that the new tablet formulation of its protease inhibitor Aluvia® (lopinavir/ritonavir), for the treatment of HIV-1, is now available to HIV/AIDS patients in South Africa a step the company hopes will positively impact millions of lives across the country.
“Today marks a new beginning for the treatment of HIV in South Africa,” said Steven Miller, professor, Innovir Institute, Johannesburg, South Africa. “Millions of patients will now have the opportunity to benefit from a highly effective, co-formulated protease inhibitor that does not require refrigeration a critical step in advancing treatment and care in a country where HIV prevalence is among the highest in the world.”
South Africa has experienced one of the most severe HIV/AIDS epidemics in the world. The Actuarial Society of South Africa estimates that, in 2006, almost half of all deaths in the country were caused by AIDS. Among adults aged 15-49 years, 71 percent of deaths were AIDS-related.
The lopinavir/ritonavir tablet (marketed as Aluvia in the developing world) is the first and only co-formulated protease inhibitor tablet that does not require refrigeration and can be taken with or without food two important advances in delivering HIV medicine, especially in developing countries. The tablet formulation also offers the increased dosing convenience of fewer pills (a total daily dose of four tablets, instead of six soft-gel capsules). Each Aluvia tablet contains 200 mg of lopinavir and 50 mg of ritonavir. The World Health Organization (WHO) has identified lopinavir/ritonavir as the recommended protease inhibitor for second-line therapy in resource-restricted countries, such as South Africa. Aluvia is always used in combination with other antiretroviral agents.
Abbott’s introduction of the Aluvia tablet in South Africa is part of its five-point global strategy to expand access to HIV treatments around the world by:
* Continuing to innovate with an eye on the needs of the developing world;
* Investing in manufacturing capacity to ensure consistent, quality supply;
* Offering tiered and affordable pricing;
* Broadening registration of life-enhancing medicines; and
* Focusing on pediatric HIV care.
“Bringing a heat-stable tablet version of lopinavir/ritonavir to South Africa is another example of Abbott’s commitment to working with the business community and health community to improve health systems and address challenges of capacity building and access in Africa and beyond,” said Scott Brun, M.D., divisional vice president, infectious diseases and immunology development, Global Pharmaceutical Research and Development, Abbott.
Lopinavir/ritonavir has been available in soft-gel capsules (known as Kaletra®) and as an oral solution since it was first approved in the United States in September 2000. Using its breakthrough Meltrex™ technology, Abbott developed the tablet formulation, which maintains a similar safety and efficacy profile as the soft-gel capsule. The tablet formulation received approval from the U.S. Food and Drug Administration in 2005 and the European Medicines Agency in 2006.
Progress on Global Registration of Lopinavir/Ritonavir Tablets
Abbott has worked diligently to register the tablet around the world. Today, the tablet is filed, available (where no regulatory approval is needed) or approved in 154 countries. The original lopinavir/ritonavir capsule is registered in 118 countries, making it the most widely registered HIV medicine in the world (according to WHO data).
The lopinavir/ritonavir tablet is now filed, available or approved in nearly every African country (48 countries), where the majority of the world’s people with HIV live. In addition to South Africa, the tablet is available or approved in: Angola, Benin, Botswana, Cameroon, Camoros, Central African Republic, Congo Brazzaville, Cote d’Ivoire, Djibouti, DR Congo, Ethiopia, Gabon, Ghana, Guinea Conarkry, Kenya, Lesotho, Libya, Malawi, Mauritius, Mauritania, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Swaziland, Tanzania, Togo, Uganda and Zambia.
Availability of Lower-Strength Lopinavir/Ritonavir Tablets
Abbott also has filed its lower-strength lopinavir/ritonavir tablet, suitable for pediatric use, in South Africa. This new formulation represents a significant advancement for clinicians and patients in developing countries, where more than 2 million of the estimated 2.5 million children with HIV/AIDS under 15 years of age, worldwide, lived in 2007. The lower-strength tablet formulation contains 100 mg of lopinavir and 25 mg of ritonavir. The lower-strength tablet is filed, available or approved in more than 80 countries around the world. Abbott intends to make the lower-strength tablet available or approved in 155 countries around the world, just as it will with the adult tablet.
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