Abbott Laboratories has been given the green light by US regulators to market a lower-strength version of Kaletra for children suffering from HIV.
The US Food and Drug Administration has approved a new lower-strength tablet formulation of Kaletra/Aluvia (lopinavir/ritonavir), which the firm says will be of great benefit to the two million children living with HIV worldwide. The tablets do not require refrigeration and can be taken with or without a meal, which Abbott notes is important in delivering such drugs to children in developing countries.
Now the company is waiting for approval from the European Medicines Agency for the lower strength tablets (100mg of lopinavir and 25mg of ritonavir, half the adult dose) and once this is forthcoming, the new formulation will then be registered in more than 150 countries. Kaletra has been available in liquid form for paediatric use since 2000 in the USA.
Abbott says that the price of the lower-strength tablet will be half that of the original tablet in the developing world, and noted that it has been providing its HIV medicines at $500 per adult patient per year in all African and least developed countries since 2002, “making these medicines more affordable than any generic copies”.
However the pricing of Kaletra has proved to be a controversial issue in the recent past and in April, Abbott cut the price of the drug to the governments of more than 40 low and low-middle income countries (as defined by the World Bank) and to non-governmental organisations by more than half. This move came in response to requests from the United Nations and threats from Brazil and Thailand to make a generic version and override the firm’s patents on Kaletra.
