Abbott has received US FDA approval for a new tablet formulation of its HIV protease inhibitor (PI) Kaletra (lopinavir/ritonavir), which will allow adult patients to take fewer pills with or without food as part of their treatment regimen. Additionally, there will be no refrigeration requirements for the tablets. These benefits were not available with the old Kaletra capsules. The standard daily doses of new Kaletra tablets and capsules provide similar drug levels in the blood.
Kaletra is the number one prescribed PI for the treatment of HIV worldwide and has been taken by hundreds of thousands of patients since the drug was introduced in 2000. According to the updated guidelines released by a panel convened by the US Department of Health and Human Services in October 2005, for the use of antiretroviral agents in HIV-1 infected adults and adolescents, Kaletra, in combination with zidovudine and lamivudine or emtricitabine, are recommended as the preferred PI-based regimens for the treatment of patients new to HIV therapy, informs a company release.
"Physicians strive to provide patients with medications that are effective against the virus and meet patient requests for simpler treatment regimens. Kaletra tablets respond to physician and patient needs by combining the new benefits of fewer pills per day, without food or refrigeration restrictions, with a drug that has a well-established clinical track record," said Calvin Cohen, M.D., research director, Community Research Initiative of New England and Harvard Vanguard Medical Associates, Boston.
The FDA approval of the Kaletra tablet formulation was based on data from pharmacokinetic studies in 141 non-HIV infected, healthy individuals. The studies demonstrated that Kaletra tablets provide similar drug levels in the blood to the capsule formulation. In these studies, Kaletra tablets were generally well tolerated.
"Abbott has a long history of innovative science in HIV and bringing forward improved treatment options for patients. With the new Kaletra tablet, we are providing patients with a more convenient version of the number one prescribed protease inhibitor for the treatment of HIV," said Scott Brun, divisional vice president, infectious disease development, Abbott.
Abbott developed new Kaletra tablets using proprietary melt-extrusion technology (Meltrex), which enables a stable, solid dispersion of Kaletra within a tablet that provides similar drug levels in the blood relative to the capsules.
Kaletra capsules were initially approved for twice-daily administration. In April 2005, the FDA also approved capsules for once-daily administration in adult patients with no prior antiretroviral treatment.