New formulation of lopinavir/r approved in Europe (Kaletra) and new tradename for access countries (Aluvia)

On 3 July 2006 Abbott announced that it has received marketing authorisation from the European Commission for the Meltrex tablet formulation of lopinavir/ritonavir (Kaletra).

The tablet reduces the daily pill count to 2 tablets, twice daily compared to 3 capsules twice daily, for standard dosing.

The new tablets do not require refrigeration (can be stored at room temperature up to 30 degrees C) and can be taken with of without food.

A single Kaletra tablet will now be composed of 200 mg lopinavir and 50 mg ritonavir, as compared to133.3mg lopinavir and 33.3mg ritonavir in the previously introduced soft capsule.

With the approval of Kaletra tablets in the EU, the vast majority of patients will convert to the tablet formulation. Patients should finish taking their current supply before starting a new prescription and should never take Kaletra tablets and capsules together.

The formulation for resource poor countries is being produced with a different coloured finishing dye: the tablet with be yellow in Europe and the US, and terracotta for access countries, where it will be marketed a with a different tradename, Aluvia (rather than Kaletra).

Capsules will remain available in special cases where they are needed, including paediatrics.

Comment

The lack of diet restrictions and need for refrigeration, together with the lower pill count should improve quality of life and is likely to be popular. Costs are not expected to rise in Europe for the new formulation.

The heat stability of this formulation makes lopinavir/r no a more realistic option for people in hot climates. The price announced by Abbott for resource limited settings is $500 year.