Abbott gets EC approval for low-dose Kaletra

US health care major Abbott has received marketing authorization from the European Commission for the new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir). The tablet can be taken with or without food and does not require refrigeration. The agent is marketed as Aluvia in developing countries.

European approval is a critical step in Abbott's efforts to expedite registration filings for the lower-strength tablet formulation in countries around the world, including in developing nations where more than two million of the estimated 2.3 million children worldwide with HIV/AIDS live. In Europe, there are approximately 4,000 children living with HIV.

Currently, the lower-strength tablet is available or approved in 53 countries in Europe, Africa, Asia, Latin America and in North America, and is filed in an additional 11. EC approval is significant for many developing nations because they require documentation of the marketing authorization to obtain a Certificate of Pharmaceutical Product - often a prerequisite for regulatory filing in developing countries. In order to expedite review, Abbott is working with regulatory agencies on a country-by-country basis to negotiate submissions before the CPP is available. The firm intends to make the lower-strength tablet available or approved in 155 countries around the world, just as it has done with the adult tablet.