The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of a new, more convenient tablet formulation of Abbott protease inhibitor (PI) Kaletra (lopinavir/ritonavir).
The European Commission decision regarding marketing authorization 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.
"Abbott has a long legacy of providing innovative treatment options to the HIV community, including improved formulations for existing products," said Scott Brun, divisional vice president, Infectious Disease Development, Abbott. "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," he added.
According to the company release, 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 United States Food and Drug Administration (FDA) approved the Kaletra tablet on October 31, 2005.
The new formulation of Kaletra will provide patients with a tablet composed of 200 mg lopinavir and 50 mg ritonavir, as compared to the current soft capsule, which contains 133.3 mg lopinavir and 33.3 mg ritonavir. While the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, the number of Kaletra pills patients need to take is reduced to four tablets from six soft capsules per day. The standard daily doses of the new tablet formulation and the current capsules provide similar drug levels in the blood.