A Food and Drug Administration advisory committee voted 12 to 4 (with one abstention) to recommend broadening Crestor's label to include the treatment of people with normal cholesterol levels and no history of heart disease. That's not a typo. A study named JUPITER ("Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin") showed that perfectly healthy older people can benefit from taking Crestor. Their low risk of heart-related problems becomes even lower when taking it.
The FDA still needs to sign off on the label change, but given the positive recommendation from the experts, and the fact that Crestor is already on the market, an FDA approval seems more likely than not.
The big question is whether the label change will actually increase sales. It'll open up the market to an additional 6.5 million people, but remember, we're talking about changing a small risk of heart issues into an even smaller one. Will people and their insurance agencies be willing to pay for it? After all, we're in a financial health-care crisis, you know.
AstraZeneca plans to market the drug to people who might have other risk factors for heart issues, like smokers. It won't be trying to get doctors to hand it out like candy -- for now, at least.
The billion-dollar question is whether the added protection is specific to Crestor or if other statins like Pfizer's
AstraZeneca better have its promotional materials ready. Who knows how long the window in the candy store will be open?
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