The European Commission decision regarding marketing authorization for Kaletra (lopinavir/ritonavir) is expected within 90 days. The anticipated marketing authorization from the European Commission also will enable Abbott to move forward with registration filings and seek approvals in developing countries.
The tablet formulation of Kaletra was developed using the proprietary Meltrex melt-extrusion technology and is designed to offer patients a number of new benefits not available with the current Kaletra capsules. These benefits include fewer tablets per dose as part of their treatment regimen, no required refrigeration, and that the drug can be taken with or without food.
The positive opinion for the tablet formulation of Kaletra was based upon data from pharmacokinetic studies. Abbott’s tablet submission was filed as a line extension to the EMEA on May 19, 2005. The FDA approved the Kaletra tablet on October 31, 2005.
The new formulation of Kaletra will provide patients with a tablet composed of 200mg lopinavir and 50mg ritonavir, as compared to the current soft capsule, which contains 133.3mg lopinavir and 33.3mg ritonavir. While the total daily dose of Kaletra (800mg lopinavir/200mg ritonavir) is unchanged, the number of Kaletra pills patients need to take is reduced to four tablets from six soft capsules per day.
“As we celebrate 10 years of protease inhibitor availability, which revolutionized HIV therapy, the Kaletra tablet offers the next step in the development of treatments directly tailored to patient needs by providing a more convenient version of the leading prescribed PI for the treatment of HIV in the European Community,” said Dr Scott Brun, divisional vice president of infectious disease development at Abbott.