AstraZeneca sees Crestor indicated for atherosclerosis

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the use of Crestor (rosuvastatin calcium) as an adjunct to diet in order to slow the progression in patients with elevated cholesterol.

The pharmaceutical company submitted its proposal for Crestor’s indication following the Meteor study which measured the cholesterol drug’s effect on plaque build-up in the arteries using carotid intima-media thickness.

It was found that Crestor demonstrated a slowing of progression of atherosclerosis in people with early signs of the disease.

Mike Tilton, vice-president of cardiovascular primary care at AstraZeneca, confirmed that in the Meteor trial, patients with hyperlipidaemia who took Crestor experienced no significant progression of atherosclerosis.

Commenting on the FDA decision, he added: “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.”

AstraZeneca has indicated that the Crestor label conforms to FDA’s revised format which is intended to drawn physicians’ attention to the most important information.

Earlier this week, AstraZeneca presented new data from its Corona study showing that optimised heart failure treatment did not significantly improve when patients with advanced heart failure were given statins.