Crestor indicated to slow progression of atherosclerosis in high cholesterol patients

Published: 9-Nov-2007
Regulatory Research & Development

The US Food and Drug Administration (FDA) has approved Crestor (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. This new indication gives the drug differentiator from competitors in the cholesterol-lowering marketplace.


The US Food and Drug Administration (FDA) has approved Crestor (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. This new indication gives the drug differentiator from competitors in the cholesterol-lowering marketplace.

The submission package to the FDA was based largely on the results of a pivotal study called METEOR (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin) which measured the effects of Crestor on plaque build-up in the arteries using carotid intima-media thickness (CIMT) and demonstrated a slowing of progression of atherosclerosis in people with early signs of the disease, elevated LDL cholesterol, and low cardiovascular risk, taking Crestor 40 mg.

AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co.

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