The new Kaletra (lopinavir/ritonavir) tablet was developed using a proprietary novel melt-extrusion technology intended to allow patients to take fewer tablets per dose as part of their treatment regimen. In addition, the tablet would not require refrigeration, as the current soft-gel capsule formulation does.
If approved, the new tablet will provide patients with a tablet composed of 200mg lopinavir and 50mg ritonavir, as compared to the current soft-gel capsule, which contains 133.3mg lopinavir and 33.3mg ritonavir. It also reduces the number of Kaletra pills patients need to take per day from six to four.
The submission package included data from bioequivalence studies and Abbott has plans to conduct clinical trials in patients living with HIV.
Kaletra has been the leading protease inhibitor (PI) for the treatment of HIV in the US since 2002, and is the only protease inhibitor listed as preferred for initial therapy in the US Department of Health and Human Services’ guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents.