The single pill would target all three major blood lipids – LDL-C “bad” cholesterol, HDL-C “good” cholesterol, and triglycerides, and combines Abbott’s next-generation fenofibrate ABT-335, which is currently in late-stage clinical trials, with AstraZeneca’s Crestor.
ABT-335 is part of a class called fibrates, which have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C. Crestor, meanwhile, is part of a class of medication called statins, which has been shown to significantly reduce LDL-C while raising HDL-C. This combination therapy is being investigated to address LDL-C, HDL-C and triglycerides simultaneously in a single pill, which could improve convenience and lipid outcomes, the companies said.
Abbott will continue executing the clinical trial program and be responsible for regulatory registration of the new combination therapy. AstraZeneca will hold the new drug application. Following successful completion of the clinical program, a regulatory application for the new combination therapy is targeted for submission in 2009. This collaboration relates to the US market.