Formal EU marketing approval has been granted for a low-dose tablet formulation of Kaletra (lopinavir/ritonavir) for paediatric use.
As reported on aidsmap.com, European approval means that the drug can receive a Certificate of Pharmaceutical Product (CPP), enabling its regulatory approval in many resource-limited countries.
In a press release, the makers of Kaletra, Abbott, said they were “working with regulatory agencies on a country-by-country basis to negotiate submissions before the CPP is available.” It added that Abbott “intends to make the lower-strength tablet available or approved in 155 countries around the world”.
Containing 100mg of lopinavir and 25mg of ritonavir, the lower-dose paediatric formulation of Kaletra contains half the standard adult dose. Approval in the US was granted in November 2007.
Like the adult Kaletra tablet dose the new paediatric tablet can be taken with or without food and does not require refrigeration.
The price of the new paediatric tablet will be half the price of the adult-strength tablet where it is available: approximately $250 per patient per year in resource-limited countries.
Following US approval in November, Abbott was able to start supplying the lower-dose tablet to some resource limited countries that issued approved waiver orders. It is currently available, or approved, in 53 countries in Europe, Africa, Asia and Latin and North America.