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AstraZeneca reaches Crestor-use goal
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.
- read the New York Times story
- get more from Forbes
- check out Bloomberg's take
- see the Reuters article
Related Articles:
Crestor gets FDA panel nod for wider use
FDA reviewer: Crestor benefits outweigh risks
Crestor shines, Vitamin D intrigues at AHA confab
Plavix, Crestor make headlines at ESC
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.
Comments
By Anonymous | Posted 4:25pm | February 11, 2010
The Framingham study evidence underlying the “lipid hypothesis†was never strong to start with. Since then a massive lipid lowering campaign has shown no effect on heart disease rates. While an elegant and seemingly intuitive hypothesis, more and more openly people are rightly questioning the wisdom of the cholesterol lowering campaign.
Cholesterol is an essential component of every cell membrane and important for myriad physiologic functions. When Dr. Uffe Ravnskov, MD PhD looked at the medical literature he found something quite surprising had been documented there. On average people with higher cholesterol live longer. Cholesterol is a mediator in heart disease but blood cholesterol levels have next to no effect on heart disease rates again heart disease rates mostly unchanged since the advent of the massive cholesterol lowering campaign. Here is something else to consider, as any chemist will tell you, cholesterol is a single molecule. How then are there "good" and "bad" cholesterol molecules. It is at best scientifically imprecise and at worst a crass marketing ploy to talk about the levels of high and low denisty lipoprotein (say it again lipoprotein i.e. a protein - they are carrier proteins) as implying different cholesterol molecules. Then again the statin cholesterol lowering drug class alone is a 30 billion dollar a year industry. This latest attempt to expand cholesterol lowering "medication" to healthy individuals with normal cholesterol is both absurd and offensive.
http://healthjournalclub.blogspot.com/
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