The European Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion on a new lower-dose tablet formulation of the protease inhibitor Kaletra (lopinavir/ritonavir) for paediatric use.
This positive opinion, from the scientific committee of the European Medicines Agency (EMEA), who regulate medicine in Europe, is a key step towards formal marketing approval by the European Union.
Containing 100mg of lopinavir and 25mg of ritonavir, the lower-dose paediatric formulation of Kaletra contains half the standard adult dose. It was approved by the Food and Drug Administration in the US last November.
Like the adult dose of Kaletra the new paediatric tablet can be taken with or without food and does not require refrigeration.
Now that a positive opinion had been received from the CHMP the paediatric Kaletra tablet will be able to receive a Certificate of Pharmaceutical Product (CPP), enabling its regulatory approval in many resource-limited countries.
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, the manufacturer of Kaletra, was able to start supplying the lower-dose tablet to some resource limited countries that issued approved waiver orders. The first such order was dispatched to Uganda in early December.
There is also a need for the paediatric Kaletra tablet in richer countries. This was demonstrated last year when a child died after receiving an overdose of the Kaletra oral solution.
Full European marketing approval for the paediatric Kaletra tablet is expected within the next 90 days.