AstraZeneca announced that 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 Crestor an important differentiator from competitors in the cholesterol-lowering marketplace.
"This new indication allows us to share what we have learned in clinical trials - that even in people with low Framingham risk score, and early signs of atherosclerosis, the disease progresses if untreated," said Mike Tilton, vice president, cardiovascular primary care, AstraZeneca. "In the METEOR trial, patients with hyperlipidaemia who took Crestor, overall experienced no significant progression of atherosclerosis."
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.
The METEOR study is part of AstraZeneca's GALAXY Programme, a large, comprehensive, long-term and evolving global research initiative designed to address important unanswered questions in statin research and to investigate the impact of Crestor on cardiovascular risk reduction and patient outcomes. To date, the GALAXY Programme has recruited more than 69,000 subjects in more than 55 countries around the world.
The new CRESTOR label conforms to the FDA's revised, easy-to-read format designed to draw physicians' attention to the most important pieces of drug information in an effort to manage the risks of medication use and reduce medical errors.
Atherosclerosis is the progressive buildup of plaque - the fatty deposits and other cells - in the inner walls of the arteries. The condition is a consequence of elevated cholesterol and for many it is a silent disease, with no visible signs or symptoms. The disease can begin in early adulthood and continues to progress for the rest of a person's life. Despite the serious nature of atherosclerosis, many people do not understand how it develops and progresses.
Crestor is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidaemia or mixed dyslipidaemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. Crestor has not be determined to prevent heart disease, heart attacks or strokes. AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co., Ltd.