Abbott submits EU filing for lower-strength Kaletra and Aluvia

Abbott has announced that it has applied for marketing approval for a new, lower-strength formulation of Kaletra and Aluvia (lopinar/ritonavir) with the European Medicines Agency.

The firm reports that the drug is the sole co-formulated protease inhibitor suitable for use in children, while the new lower-strength tablets will complement Kaletra oral solution, which has been on the market since September 2000.

Additionally, the new formulation of Kaletra and Aluvia will be available for lower prices in the developing world, while the price of the drug will be half that of the standard, full-strength formulation.

The lower strength formulation of the drug contains 25 mg of ritonavir and 100 mg of lopinavir, half the strength of the existing tablet.

Scott C Brun, divisional vice-president of infectious disease, renal development and global pharmaceutical research and development at Abbott, said: “Abbott’s lower-strength tablet formulation of lopinavir/ritonavir is a significant innovation in the care for people living with HIV.”

He added that the development of this drug is part of the firm’s dedication to producing innovative treatment options for patients with HIV worldwide, included the developing world.

Abbott announced the receipt of marketing approval for the tablet formulation of Kaletra in July 2006, giving patients more convenient treatment option which does not require refrigeration.