The Kaletra (lopinavir/ritonavir) tablet allows adult patients to take fewer pills with or without food as part of their treatment regimen while maintaining the same safety and efficacy. In addition, the new formulation does not require refrigeration.
This approval will complement Abbott’s efforts to expedite registration filings for the tablet formulation in countries around the world, including in developing countries. To date, Abbott has filed for registration of the new tablet formulation in countries in Africa, Asia and Latin America.
Many developing countries require documentation of European approval as part of the filing process for the new tablet formulation. Abbott aims to obtain the necessary documentation and proceed with the filing process in these countries as rapidly as possible.
“Kaletra is a proven HIV treatment, and this new and more convenient tablet formulation is welcomed by both physicians and patients,” said Dr Martin Fisher, consultant physician in HIV and Genitourinary Medicine at the UK’s Brighton and Sussex University Hospitals.