Citing the findings of AstraZeneca’s last-November study, a Food and Drug Administration (FDA) medical reviewer posted online on Friday said that the benefits of the British drugmaker’s cholesterol-lowering pill ‘Crestor’ outweighs the risks associated with the drug.
AstraZeneca, which is seeking FDA approval for a wider use of Crestor, sponsored a study that involved nearly 18,000 patients with normal or slightly elevated cholesterol levels, but high C-reactive protein levels.
Comparing the patients on Crestor to those who received a placebo or a fake pill, the study found that, after an average of 1.9 years, there was a 44 percent decrease in the number of incidents involving a combination of death, stroke, heart attacks, hospitalization for heart problems, and surgery for the treatment of clogged arteries.
Adding that though Crestor lowers the risk of heart attack, death and stroke in patients who do not have a history of heart disease, the drug still has some safety concerns, for which additional study is required to further gauge its “benefit-risk ratio.”
With AstraZeneca looking to sell Crestor to a more extensive group of patients who, under the existing guidelines, would otherwise not be considered candidates for cholesterol-lowering drugs, the Crestor pill will be reviewed by the endocrinologic and metabolic drugs advisory committee of the FDA on Tuesday. The committees will vote to ascertain whether a wider group of patients should qualify for Crestor.












