Tuesday, 27 April 2010 at 11:35, Reuters, London
AstraZeneca has won European approval to promote cholesterol fighter Crestor for preventing heart disease in a large new market of people with healthy cholesterol but other heart risks. Tuesday's decision to approve the new use in 19 European Union countries follows a similar green light from the US Food and Drug Administration in February. The approval was based on data from a nearly 18,000-patient study funded by AstraZeneca, called Jupiter, which looked at Crestor's positive impact on people with high levels of C-reactive protein (CRP) plus at least one other risk factor. CRP is a sign of inflammation associated with heart disease. Wider approval for Crestor is likely to boost sales of the drug, but industry analysts say the size of the opportunity is unclear because of the looming arrival of cheaper generic versions of Pfizer's rival Lipitor in late 2011. AstraZeneca also looks set to settle a US federal investigation into its marketing practices for the antipsychotic drug Seroquel this week for $520m. An AstraZeneca spokeswoman in London declined to comment on the newspaper report but pointed out the company said at its third-quarter results last year it had reached an agreement in principle with the US attorney in Philadelphia on the matter and had set aside $520m as a provision in 2009.
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