Crestor becomes first statin approved by FDA for atherosclerosis

WILMINGTON, Del. The Food and Drug Administration has approved AstraZeneca’s cholesterol medication Crestor as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. Atherosclerosis occurs when cholesterol building up in the artery wall becomes lesions that are called plaques, and which can eventually cause heart attacks and strokes from reduced blood flow.

According to AstraZeneca, Crestor is the first statin drug to be approved by the FDA for the treatment of atherosclerosis. This class of drugs includes such blockbuster drugs as Lipitor, Zocor and Pravachol. For the 12-month period ending March 2007, the statin market had sales of $18.7 billion in the U.S., according to IMS Health. Lipitor, the leader in this category, as well as the world’s best selling drug, had sales of $12.8 billion in 2006. Crestor brought in over $2 billion for AstraZeneca last year, making it the company’s third-best selling product.

“This new indication gives Crestor an important differentiator from competitors in the cholesterol-lowering marketplace,” AstraZeneca said in a statement. At the beginning of the month, it was announced that Cobalt Pharmaceuticals had filed for a generic version of Crestor. While that move would not have an immediate impact on sales of the drug, this new approval for AstraZeneca certainly will.