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FDA approves atherosclerosis drug


AstraZeneca has announced that the Food and Drug Administration (FDA) has approved Crestor (rosuvastatin calcium) to reduce atherosclerosis in patients with high cholesterol levels.

The firm’s submission to the FDA was based on the results of a study called METEOR – Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin.

It looked at the impact of Crestor on plaque build-up in the arteries, and showed it can slow the progression of atherosclerosis in people with early signs of the disease.

The METEOR study is part of AstraZeneca’s GALAXY Programme, a long-term global research initiative designed to address important questions in statin research, and to investigate the effect of Crestor on cardiovascular conditions.

The programme has recruited more than 69,000 subjects in more than 55 countries around the world.

Atherosclerosis is the progressive buildup of plaque in the inner walls of the arteries. The condition arises from elevated cholesterol and for many people it is a silent disease, with no visible symptoms.

The new Crestor label conforms to the FDA’s revised, easy-to-read format that is designed to draw attention to the most important pieces of drug information in an effort to reduce medication errors.

Copyright © PA Business 2007


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