Statin for slowing atherosclerosis progression gets FDA OK

November 13, 2007

New indication for rosuvastatin (Crestor) approved.

AstraZeneca has received word from the FDA that it can go ahead and market rosuvastatin calcium (Crestor) for a new indication. The statin has been approved as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. The regulatory green light was based on results of the company's METEOR study, which evaluated the effect of the drug on artery plaque buildup as measured by carotid intima-media thickness. A slowing of the progression of atherosclerosis in patients taking 40 mg of rosuvastatin was observed. The statin is also indicated as adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, ApoB, non HDL-C, and triglycerides and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.

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