AstraZeneca's Crestor has scored. The cholesterol drug is one of only two statins that can now be marketed as a preventive, not just a treatment. And that's the FDA approval AstraZeneca needed to help fight rival statins that are going off patent. That includes the great gorilla of statin drugs--indeed of all drugs--Pfizer's Lipitor.
AstraZeneca sponsored a huge study--almost 18,000 patients--to see how Crestor worked in people whose cholesterol fell within normal limits but whose C-reactive protein was elevated. CRP is an indicator of inflammation, a sort of precursor to full-blown cardiovascular disease. The JUPITER study showed that patients using Crestor had a significantly lower rate of cardio problems compared with patients on placebo.
So does this mean that doctors will be pulling blood testing and writing Crestor scrips for everyone whose CRP is elevated? The FDA hopes not; an advisory panel that recommended Crestor for the new indication worried that the drug might be used in too many patients at low risk of heart disease. In the JUPITER study, in fact, the drug helped patients with high CRP who also had other risk factors--like high blood pressure or family history--but didn't help patients without additional risk factors.
Either way, this new indication opens up a huge new market for the drug; some 6 million patients would qualify, the FDA said. And since Crestor still has several years of patent coverage left, AstraZeneca can reap the benefits. No doubt there's a Crestor ad campaign on its way to a TV or magazine near you.
Editor's Note: This article originally stated that Crestor was the only statin approved to be marketed as a preventative treatment. Lipitor also carries that approval.