Abbott's new tablet formulation for HIV drug Kaletra approved in Europe

By E. Janene Geiss

Philadelphia, July 3 - Abbott said Monday that it has received marketing authorization from the European Commission for the tablet formulation of Kaletra (lopinavir/ritonavir), a new, more convenient version of the protease inhibitor 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, according to a company news release.

In addition, the new formulation does not require refrigeration.

This approval will complement Abbott's efforts to expedite registration filings for the tablet formulation in countries around the world, including in developing countries, officials said.

To date, Abbott said it 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 said it will be obtaining the necessary documentation and moving forward with the filing process in these countries as rapidly as possible.

Benefits of the new formulation include a reduced pill count. The total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, but patients will now only need to take four tablets per day, as opposed to six capsules, officials said.

The tablets can be taken with or without food, providing patients greater flexibility. The current soft capsule formulation should be taken with food.

The tablets do not require refrigeration. Unlike the soft capsule, the tablet can be stored at room temperature.

The approval of the tablet 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 Food and Drug Administration approved the Kaletra tablet on Oct. 31, 2005, officials said.

Abbott is an Abbott Park, Ill., health care company.

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