Yesterday afternoon, Dec. 15, an FDA advisory panel voted 12-4 in favor of AstraZeneca’s application to broaden its labeling for rosuvastatin (Crestor) to include patients who meet enrollment criteria from the company’s large JUPITER study.
In short, the new indication would approve use of rosuvastatin for patients who have “normal” blood levels of LDL cholesterol (less than 130 mg/dL), but have elevated blood levels of high sensitivity C-reactive protein (hsCRP), a marker of systemic inflammation (a level of 2.0 mg/dL or higher).
If the panel’s vote, the first formal vetting of the JUPITER results by a policy-setting group, leads to FDA action, the gates will open to several million more people as candidates for daily statin treatment. But because the various other statins on the market, notably atorvastatin (Lipitor) and generic simvastatin, are used by physicians fairly interchangeably with rosuvastatin (and rightly so), the FDA panel’s decision is really more about endorsing a pivotal role for measuring hsCRP and treating a high level and less about any special role for Crestor.
Sure, if the FDA goes along with its panel AstraZeneca will gain a useful marketing chip for its proprietary statin. But it’s common knowledge that Crestor is not unique among statins in its ability to lower hsCRP levels. Several other statins do it too, and it’s clearly a class effect.
Fine-tuning public health policy on how to use hsCRP to guide statin therapy is still needed, and it’s something that the National Heart, Lung and Blood Institute’s cholesterol-treatment committee is now struggling with as it works on an upate of the Adult Treatment Panel guidelines.
The dilemma physicians face was distilled in quotes that Carlene Olsen had in her article in today’s The Pink Sheet Daily on the FDA’s panel’s Crestor vote. She spoke with panel member Dr. William R. Hiatt, professor of medicine at the University of Colorado in Denver:
“I voted yes, because I’m concerned about the ethical issue of denying a majority of the population [preventive treatment]…But I do believe there are patients in this study who really shouldn’t receive this drug. Should we add CRP to the decision making? I think the study and the population convincingly say to me that we should, but I’m not sure how far with this we should go.”
—Mitchel Zoler (on Twitter @mitchelzoler)