Abbott Announces Statin, Fibrate Combination In A Single Pill
Abbott and AstraZeneca will advance the development of Abbott's next-generation fenofibrate ABT-335 and AstraZeneca's CRESTOR (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III clinical trials. The single pill would target all three major blood lipids -- LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.
ABT-335 is Abbott's next-generation fenofibrate currently in late-stage clinical trials. Based on the significant progress made in the ABT-335 and CRESTOR fixed-dose combination development program, the companies have jointly decided to move forward with this fixed-dose combination therapy. The studies are proceeding on schedule.
"This decision highlights the opportunity for broader treatment in many higher at-risk populations," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "We're looking forward to exploring the potential of a combination treatment to address the needs of patients."
"AstraZeneca is committed to continually investigate new treatment options for patients at risk for cardiovascular disease," said James Blasetto M.D., Vice President, Strategic Development, AstraZeneca. "The combination of CRESTOR and ABT-335 may be an important option to help patients with mixed dyslipidemia achieve their treatment goals."
ABT-335 and CRESTOR are both lipid-regulating agents. ABT-335 is an investigational compound that is part of a class of medications called fibrates. Fibrates have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C.
CRESTOR 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.
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.
ABT-335 is a next-generation fenofibrate in clinical development for abnormal lipids in the bloodstream, including cholesterol and triglycerides. In addition, based on the positive results from ABT-335's clinical trial program, Abbott plans to file ABT-335 as a monotherapy (as an adjunct to diet) by the end of 2007. Abbott is currently evaluating ABT-335 as a co-administered therapy with other on-market statins, including CRESTOR, and expects to present data from the clinical trials in the first half of 2008.
CRESTOR (rosuvastatin calcium) is a once-daily, lipid-lowering agent prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C>190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.