Abbott has received marketing authorization from the European Commission for the tablet formulation of Kaletra (lopinavir/ritonavir), a new, more convenient version of the leading protease inhibitor (PI) prescribed worldwide for the treatment of HIV.
The Kaletra tablet allows adult patients to take fewer pills with or without food as part of their treatment regimen while maintaining the same safety and efficacy. In addition, the new formulation does not require refrigeration, an Abbott release stated.
This approval will complement Abbott's efforts to expedite registration filings for the tablet formulation in countries around the world, including in developing countries. To date, Abbott has filed for registration of the new tablet formulation in countries in Africa, Asia and Latin America. Many developing countries require documentation of European approval as part of the filing process for the new tablet formulation. Abbott will be obtaining the necessary documentation and moving forward with the filing process in these countries as rapidly as possible.
"Kaletra is a proven HIV treatment, and this new and more convenient tablet formulation is welcomed by both physicians and patients," said Dr. Martin Fisher, consultant physician in HIV and Genitourinary Medicine, Brighton and Sussex University Hospitals.
The approved tablet formulation of Kaletra is designed to offer patients new benefits not available with the current soft capsules, enhancing the dosing convenience without compromising efficacy.
Reduced pill count - though the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, patients will now only need to take four tablets per day, as opposed to six capsules
Dosing with or without food, providing patients greater flexibility - the current soft capsule formulation should be taken with food
No required refrigeration - unlike the current soft capsule formulation, which requires refrigeration, the new Kaletra tablet can be stored at room temperature
Kaletra was developed using the proprietary Meltrex melt-extrusion technology, a formulation process resulting in a stable, solid dispersion of Kaletra, translating to fewer pills while maintaining the same amount of lopinavir and ritonavir. A single Kaletra tablet will now be composed of 200 mg lopinavir and 50 mg ritonavir, as compared to 133.3 mg lopinavir and 33.3 mg ritonavir in the previously introduced soft capsule.
"The tablet formulation of Kaletra is another example of Abbott's continued commitment to offering the next step in simple, safe and effective treatments for the HIV community," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott.
The approval of the tablet formulation from the European Commission was based on data from pharmacokinetic studies. The Kaletra 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.
With approval of the more convenient Kaletra tablets in the EU, the vast majority of patients will convert to the tablet formulation. Patients should finish taking their current supply before starting a new prescription, should never take Kaletra tablets and capsules together, and should follow their doctor's directions, exactly as written on the label. Capsules will remain available in special cases where they are needed, including paediatrics.
To assist with the conversion from Kaletra capsules to Kaletra tablets, Abbott is providing educational information to health care providers and the HIV community.