PHARMA: Statin redux as FDA issues new advisory for Crestor

(Hat-tip to Sydney at Medpundit for this one). The FDA late last week issued a new advisory for Crestor, Astra-Zeneca’s blockbuster statin. THCB readers not suffering from medium term memory loss might remember a series of articles from various interested contributors late last year that were started mostly by the British medical journal The Lancet. That journal was highly critical of Astra-Zeneca’s stance in getting the drug through the FDA. I’m not enough of a pharmacy expert to interpret the FDA’s latest advisory, but the key section says:

    FDA has received reports of rhabdomyolysis in association with Crestor, as it has with other drugs in the statin class. In ongoing fashion, we are evaluating these reports of adverse muscle effects with regard to clinical severity and apparent relationship to the drug. FDA is comparing the frequency of reporting of muscle injury with Crestor to that with other statins, given differences in prescribing rates for the different drugs. Pending the evaluation of the recent Crestor safety experience, FDA is not proposing to change the US labeling for Crestor, but does want to re-emphasize to physicians to the importance of carefully following the recommendations in the current product label. Analysis of accumulating safety data in the U.S. and worldwide will be considered in any future labeling changes for Crestor, and to make recommendations on risk management plans for Crestor.

Crestor’s removal from the market is still an extremely unlikely wildcard, and those who suggested shorting AZ’s stock last year have seen it stay in a tight $45-50 range since the Crestor launch. I’ll try to raise more information about the statin market, but given that in 2003 Lipitor and Zocor had $16 billion in sales between them, you understand that developments like this in the statin market are very serious business. But like everything else these days you can bet on it in an online idea futures market.

Meanwhile, if you were concerned that high cholesterol may not be a sufficiently nebulous condition to demand all this attention, don’t worry. Metabolic syndrome has been pushed by the pharma press for a year or so now and it makes its first appearance (at least first one that I’ve noticed) in a mainstream business publication (Forbes)today. The article is appropriately enough called Inventing a New Heart Disease.

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