Abbott's anti-HIV tablet gets marketing approval recommendation from European Medicines Agency

By Elaine Rigoli

Tampa, Fla., April 28 - Abbott announced Friday that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has issued a positive opinion recommending approval of a new, more convenient tablet formulation of its protease inhibitor 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, according to a news release.

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, including:

• Fewer tablets per dose as part of their treatment regimen;

• No required refrigeration, before or after dispensing (unlike the current soft-capsule formulation, which requires refrigeration);

• Can be taken with or without food.

The Food and Drug Administration approved the Kaletra tablet Oct. 31, 2005.

Abbott is an Abbott Park, Ill.-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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