Abbott has filed for permission on both sides of the Atlantic to market a new, lower-strength pill of its blockbuster HIV protease inhibitor Kaletra/Aluvia (lopinavir/ritonavir), which is suitable for paediatric use.
According to the company, the drug is the first and only co-formulated protease inhibitor tablet that can be used in children, and the new pill “will complement the availability of Kaletra oral solution,” which first hit the market in September 2000.
If it gets the green light, the new, lower-strength pill will offer more dosing flexibility for suitable paediatric patients than the currently approved full-strength one, Abbott said. Furthermore, it pointed out, the new tablet version offers the important advantage of not needing refrigeration and can be taken with or without food.
“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," explained Professor Diana Gibb, 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.”
Abbott says it intends to make the new version available globally as broadly as the already-approved tablet which, at 150 countries, will be the most widely registered HIV medicine in developing countries. The price of lower-strength tablet will be half the price of the full-strength one.