Abbott's new Kaletra formulation for patient convenience approved by FDA

By E. Janene Geiss

Philadelphia, Oct. 31 - Abbott announced Monday that it received U.S. Food and Drug Administration approval for a new tablet formulation of its HIV protease inhibitor Kaletra, which will allow adult patients to take fewer pills with or without food and with no refrigeration required.

These benefits were not available with the old tablets of Kaletra, the No. 1 prescribed protease inhibitor for the treatment of HIV worldwide.

"Physicians strive to provide patients with medications that are effective against the virus and meet patient requests for simpler treatment regimens," Calvin Cohen, research director, Community Research Initiative of

New England and Harvard Vanguard Medical Associates, Boston, said in a company news release. "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."

The U.S. Department of Health and Human Services released updated treatment guidelines last month, stating, "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."

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, officials said.

The new formulation will be available in drug stores across the country in the next few weeks, officials said.

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