Abbott's new Kaltera tablet gets CHMP's OK

USA-based health care major Abbott Laboratories says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has recommended approval of a new tablet formulation of its protease inhibitor Kaletra (lopinavir/ritonavir).

The drug, which is approved by the EMEA for the treatment of HIV, is currently available in a capsule formulation which comprises 133.3mg of lopinavir and 33.3mg of ritonavir. The CHMP's positive opinion relates to a new tablet formulation of the compound, developed using the firm's Meltrex melt-extrusion technology, which combines 200mg of lopinavir and 50mg of ritonavir. The company says that the new formulation reduces the number of tablets required, does not need refrigeration and can be taken with or without food.

The CHMP's decision is based on data from a pharmacokinetic assessment of the product that Abbott submitted to the EMEA last year (Marketletter May 9, 2005), and follows the US Food and Drug Administration approval that it received late in 2005.