Crestor Backed by FDA for Patients With Normal Cholesterol Levels

AstraZeneca (AZN) scored a win on Tuesday, when a Food and Drug Administration advisory panel recommended broader use of Crestor, the company's cholesterol-lowering drug. The panel recommended that those with low cholesterol use the drug, following studies finding that Crestor reduces the risk of heart disease even in those with normal cholesterol levels.%%DynaPub-Enhancement class="enhancement contentType-HTML Content fragmentId-1 payloadId-61603 alignment-right size-small"%%

If the FDA follows through with the recommendation, Astra could market Crestor to those with LDL ("bad" cholesterol) levels under 130 mg/dL (but with certain markers), increasing the drug's market by as many as 6 million people, according to FDA documents.

An AstraZeneca-sponsored study of 17,802 older people with normal LDL levels and a high level of the inflammatory marker showed that its drug reduced the risk of death from heart disease by 20% and the risk of stroke or cardiovascular death by 44%. A follow-up study published on December 11 in the Journal of the American College of Cardiology confirmed the results.

Astra has asked the FDA to change the label on Crestor to reflect the study, and 12 of 17 members of the FDA's advisory panel voted in favor, saying the benefit of treating additional patients with Crestor outweighs the risks but that further risk-benefit analysis is necessary, given the short trial and the unknown longterm effects.

Crestor would be the first statin approved for primary prevention of heart disease, which most cardiologists found encouraging. Analysts believe the survey's results could expand the statin market by 20% to 50% by volume and could boost Crestor's sales, totaling $3.6 billion in 2008.

Two other statins share Crestor's market: Zocor, now available in generic form, and Pfizer's (PFE) Lipitor, set to lose patent protection in 2011. But Crestor's price -- it's the most expensive statin on the market -- may pose a problem for a drug marketed as a preventative (especially if its rivals produce similar studies and results).

Crestor is not without risks: 13 deaths have been associated with the drug, but reviewers say that could have been by chance. Eighteen patients reported being in a "confused state" while taking the drug. Most disturbing was an uptick in the new onset diabetes.

Also, Astra has failed to win a summary judgment in a patent battle over Crestor. The main U.S. patent protecting the medicine until 2016 is being challenged by a group of generics manufacturers in a trial that starts next year. So while analysts predict Crestor sales could nearly double by 2013 even without the broader use, Astra clearly faces challenges.

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