Abbott Kaletra
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Combination protease inhibitor lopinavir/ritonavir received accelerated approval from FDA Sept. 15, two and a half months after its NDA was submitted. Abbott expects to submit data for full approval within two years. The submission will contain final study reports on a head-to-head study with Pfizer/Agouron's Viracept (nelfinavir) and data from an open trial of Kaletra vs. investigator-selected PIs in combination with Roxane's Viramune (nevirapine) and two nucleoside reverse transcriptase inhibitors in previously treated patients. Kaletra is indicated for use "in combination with other antiretroviral agents for the treatment of HIV infection" in patients six months and older and is dosed twice daily. Abbott is conducting a 35-patient study of once-daily Kaletra administratio