An expert panel has advised the Food and Drug Administration to green light Crestor, AstraZeneca’s cholesterol-buster, for a wider role in the prevention of cardiovascular disease. FDA acceptance of the panel’s recommendations could markedly increase utilization of Crestor and drugs like it.
The recommendation follows release of data from the so-called Jupiter trial, which was sponsored by AZ. In Jupiter, Crestor reduced the risk of heart attacks in apparently healthy adults with no prior history of cardiac disease and normal cholesterol levels.
Participants in Jupiter did have elevated levels of C-reactive protein (CRP), a non-specific marker for inflammation that identifies people at risk for cardiac events regardless of their cholesterol levels.
Jupiter participants who took Crestor experienced a 54% reduction in the risk of heart attack and a 48% reduction in the risk of stroke. They were 46% less likely to require angioplasty or coronary bypass surgery and had 20% lower mortality from all causes.
In reaching its decision, the expert panel noted that Crestor patients developed diabetes at a higher rate than the placebo group, and experienced more deaths due to GI disease and more episodes of mental confusion. But the panel felt these events were due to chance rather than Crestor itself.
AZ wants the FDA to authorize a discussion of the Jupiter study on Crestor’s label, since this would permit the company to market Crestor to a much wider patient population.
Crestor already generates $3.6 billion in annual revenues for AZ, which is good for 9% of the US market. Pfizer’s Lipitor (27%) and generic statins (49%) have the lion’s share of this market.
Both Lipitor and the generic simvastatin have been shown to lower CRP levels. It is estimated that the label modifications would apply to about 6 million US patients.