Abbott Obtains European Approval For Kaletra Tablet

Abbott has received marketing authorisation from the European Commission for once-daily dosing of Kaletra (lopinavir/ritonavir) tablet, the company’s lead HIV protease inhibitor (PI), in adult patients new to HIV therapy.

The Kaletra tablet is now approved for once-daily as well as twice-daily use in the patient population, in combination with other antiretroviral agents, giving physicians another option when deciding on the most appropriate HIV dosing regimen.

Kaletra is an inhibitor of human immunodeficiency virus (HIV) protease enzyme used for the treatment of HIV-1 infected adults and children above the age of two years.

Reportedly, the new dosing indication is available in cases where once-daily Kaletra administration is considered necessary for the management of the patient. Kaletra dosed once-daily might be associated with a lesser sustainability of virologic suppression and a higher risk of diarrhea, compared to the recommended standard twice-daily dosage.

Scott Brun, divisional vice president of infectious disease development, Global Pharmaceutical Research and Development at Abbott, said: “The approval of this new dosing option for Kaletra in Europe is valuable for adult patients who may benefit from being able to take their prescribed Kaletra regimen one time each day. Once-daily dosing of a co-formulated tablet, such as Kaletra, is especially important for patients whose life circumstances present challenges to treatment compliance.”