Abbott announced its next advancement in the fight against paediatric HIV/AIDS. Abbott has applied to the European Medicines Agency (EMEA) and to the US Food and Drug Administration (FDA) for approval of a new, lower-strength tablet of its leading HIV protease inhibitor, known as Kaletra and Aluvia (lopinavir/ritonavir).
Abbott's lopinavir/ritonavir tablet is the first and only co-formulated protease inhibitor tablet that can be used in children. The new tablet formulation will complement the availability of Kaletra oral solution, which has been available since September 2000. The new tablet formulation does not require refrigeration and can be taken with or without a meal.
All lopinavir/ritonavir formulations are among the lowest priced protease inhibitors in the developing world. In all countries where the lower-strength lopinavir/ritonavir tablet will be available, the price of lower-strength tablet will be half the price of the full-strength tablet, an Abbott press release stated.
According to the World Health Organization (WHO), 2.3 million children under the age of 15 are living with HIV/AIDS worldwide; 1,400 children die from AIDS-related illnesses each day; and an additional 1,800 children are infected with HIV daily. The WHO recommends lopinavir/ritonavir for the treatment of children who no longer respond to first-line HIV medicines. The US Department of Health and Human Services recommends lopinavir/ritonavir for the initial treatment of children with HIV.
"Antiviral medicines can make a significant difference especially for a child," said Pamela W. Barnes, president and CEO of the Elizabeth Glaser Paediatric AIDS Foundation. "When children have HIV treatment made in a dose and form they are able to take, we can give health care providers medicines to help treat these children and manage their disease."
Given the needs in the developing world, Abbott intends to make the new lower strength tablet available globally as broadly as the already-approved tablet, which at 150 countries, will be the most broadly registered HIV medicine in developing countries. Abbott is working to ensure availability for the developing world as quickly as possible. An important first step occurred when Abbott received accelerated review by the EMEA and a priority review by the FDA. The regulatory review process in the developing world requires EMEA approval first to obtain a Certificate of Pharmaceutical Product (CPP), which must be included with the regulatory filing documents at the time of submission. As a result, Abbott is working with global regulatory agencies on a country-by-country basis to negotiate early regulatory submissions (before the CPP is available) with local governments. Abbott is and will continue to explore all locally acceptable regulatory opportunities to help make the product available to patients as soon as possible.
"There are more than 2 million HIV-infected children across the world and the majority live in resource-limited settings where access to a refrigerator and regular meals are not a guarantee," said Prof. Diana Gibb, M.D., department of infectious diseases, Great Ormond Street Hospital for Children, London, UK. "The development and approval of Abbott's lower-strength lopinavir/ritonavir tablet will add to the value of this product for treating children living with HIV."
The lower-strength tablet contains 100 mg of lopinavir and 25 mg of ritonavir compared with the current tablet strength of 200 mg of lopinavir and 50 mg of ritonavir.
Paediatric dosing of Kaletra is based on body surface area or weight. When approved, the new, lower-strength tablet will offer more dosing flexibility for suitable paediatric patients than the currently approved full-strength tablet. The oral solution of lopinavir/ritonavir continues to be available for patients around the world, though it must be taken with food and also requires refrigeration.
"Abbott's lower-strength tablet formulation of lopinavir/ritonavir is a significant innovation in the care for people living with HIV," said Scott C. Brun, M.D., divisional vice president, infectious disease/renal development, Global Pharmaceutical Research and Development, Abbott. "It is part of Abbott's continued commitment to develop the most novel formulation options for HIV patients around the world, especially in developing nations where the burden is greatest, and make them affordable and accessible."