FDA Panel Recommends Approval for AstraZeneca's Crestor

The agency usually follows the advice of its advisory panels.
Publish date:

Updated from 4:05 p.m. EDT

An advisory panel to the Food and Drug Administration has voted to recommend the approval of Crestor, a drug from


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that's designed to lower cholesterol.

The panel's decision was unanimous. Though the FDA isn't required to follow the advice of its panels, it usually does.

"The committee's unanimous recommendation to approve Crestor represents a vote of confidence in the clinical profile of Crestor," AstraZeneca said in a press release. "We believe that once approved, Crestor will provide patients who are untreated or not at their target cholesterol levels with an important new treatment option in the control of elevated cholesterol."

Crestor is in the same class of drugs as Lipitor from


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and Zocor from


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, called statins.

AstraZeneca said the clinical development program for Crestor is the largest preapproval program ever submitted to evaluate the safety and efficacy of a new statin. More than 12,500 patients are included in the safety database, with more than 4,000 patients receiving the 40-milligram dose.

The company licensed the worldwide rights to Crestor from Japanese pharmaceutical company Shionogi & Co. The drug was first approved in the Netherlands in 2002. Since then, 23 other countries have cleared the product.

Shares of AstraZeneca were rising 77 cents, or 1.8%, to $42.67 in afternoon

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