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Kaletra tablet for children coming soon, says Abbott
Keith Alcorn, Sunday, July 22, 2007
A heat stable tablet formulation of lopinavir/ritonavir (Kaletra or Aluvia) for children is now under review by the US Food and Drug Administration and the European regulatory agency, the EMEA, Abbott Laboratories announced on Friday

Abbott has been granted priority review status by both EMEA and FDA.

The heat-stable tablet does not require refrigeration and can be taken with or without food.

Tablet formulations of drugs for children are urgently required in developing countries, where distribution, storage, refrigeration and dosing of liquid formulations is extremely challenging.

Lopinavir/ritonavir is the preferred protease inhibitor for children in the World Health Organization’s paediatric treatment guidelines and was one of the formulations described as urgent by an international expert panel convened by WHO in 2006.

"There are more than two 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 Professor Diana Gibb of Great Ormond Street Hospital for Children, London. "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 100mg of lopinavir and 25mg of ritonavir compared with the current tablet strength of 200mg of lopinavir and 50mg of ritonavir.

Abbott says that the lower-dose tablet will cost half the price of the full strength adult tablet in all countries eligible for the discounted adult price of $1000 a year.

Abbott says it is “rapidly filing applications worldwide so that the pediatric formulation is as widely available as the adult formulation in 150 countries. We are currently working with global regulatory agencies to negotiate early regulatory submissions to help make the lower-strength lopinavir/ritonavir tablet for pediatric use available in those areas of greatest need as soon as possible.”