Abbott announced that it has received US Food and Drug Administration (FDA) approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir), which is also marketed as Aluvia (lopinavir/ritonavir) in developing countries. The lower-strength Kaletra tablets will be available in the US this month.
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. The soft gel capsule formulation of LPV/r is the most widely registered protease inhibitor in the world. The original tablet formulation is already available in 93 countries and Abbott is awaiting approval in an additional 45 countries for this formulation.
Approval of this lower-strength Kaletra tablet represents an important step in Abbott's ongoing commitment to the global fight against HIV because:
" 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 World Health Organization (WHO) estimates 2 million children were living with HIV/AIDS in sub-Saharan Africa at the end of 2006.
" The new lower-strength tablets are smaller in size than original Kaletra tablets and contain the same proven active ingredients as Abbott's Kaletra oral solution. The lower-strength Kaletra tablet is approved for children weighing 15kg or more who are able to swallow the intact tablet.
" The FDA approval expands available options for using the first and only co-formulated protease inhibitor tablet to treat children with HIV.
"HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world," said Scott Brun, M.D., divisional vice president, infectious diseases and renal development, Global Pharmaceutical Research and Development, Abbott. "Abbott developed a lower-strength tablet formulation of Kaletra to give physicians an innovative treatment option to help curb the impact of HIV infection in children."
The price of the recently approved lower-strength tablet will be half the price of the original tablet in the developing world.
The new tablet formulation will complement Kaletra oral solution, which has been available for paediatric use since its approval in September 2000 in the United States. For paediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility and contains 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.
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.
Abbott has made significant investments in expanding manufacturing capacity to meet the growing demand for HIV treatment in developing countries.
Abbott's lopinavir/ritonavir formulations are among the lowest-priced protease inhibitors in the developing world. Abbott has been providing its HIV medicines at a price of $500 per adult patient per year in all African and least developed countries (LDCs) since 2002, making these medicines more affordable than any generic copies.
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.
Abbott and Abbott Fund have also announced several efforts to expand access to treatment and care for children living with HIV/AIDS, including an additional investment of $12 million in grants and product donations this year.
Kaletra (lopinavir/ritonavir) is a human immunodeficiency virus-1 (HIV-1) protease inhibitor. Kaletra is always used in combination with other anti-HIV-1 medicines for the treatment of HIV-1 infection. Kaletra is a combination of two medicines, lopinavir and ritonavir. Kaletra is for adults and for children age 6 months and older.
Kaletra does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others, the company said.
Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. Abbott has developed two protease inhibitors for the treatment of HIV.
Expanding on its scientific contributions, Abbott and Abbott Fund have invested more than $100 million in developing countries to improve the lives of people affected by HIV/AIDS through programs targeting critical areas of need, including strengthening health care systems and supporting children affected by HIV/AIDS and advancing HIV testing and treatment.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.