Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has approved Abbott's new tablet formulation of its HIV protease inhibitor, Kaletra, which means patients will need to take fewer pills to achieve the same level of inhibition as afforded by the old capsule formula.
Subscribe to our email newsletter
Additionally, there will be no refrigeration requirements for the tablets, benefits not available with the old Kaletra capsules.
The FDA approval of the Kaletra tablet formulation was based on data from pharmacokinetic studies in 141 non-HIV infected healthy individuals. The studies demonstrated that Kaletra tablets provide similar drug levels in the blood to the capsule formulation. In these studies the tablets were generally well tolerated.
Kaletra is the most prescribed protease inhibitor for the treatment of HIV worldwide and has been taken by hundreds of thousands of patients since it was introduced in 2000.
“Kaletra tablets respond to physician and patient needs by combining the new benefits of fewer pills per day, without food or refrigeration restrictions, with a drug that has a well-established clinical track record,” said Dr Calvin Cohen, research director, Community Research Initiative of New England and Harvard Vanguard Medical Associates, Boston.