for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up
Healthcare

UPDATE 1-AstraZeneca wins wider EU label for Crestor drug

* Wider EU use follows similar U.S. approval in Feb

* Expansion based on findings of Jupiter clinical study

* AstraZeneca seen settling U.S. Seroquel marketing case

(Adds context on U.S. approval, company comment on Seroquel)

LONDON, April 27 (Reuters) - AstraZeneca AZN.L 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 U.S. 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 PFE.N rival Lipitor in late 2011. AstraZeneca also looks set to settle a U.S. federal investigation into its marketing practices for the antipsychotic drug Seroquel this week for $520 million.

The New York Times reported that the U.S. Justice Department would disclose details of the agreement on Wednesday, the day before AstraZeneca announces first-quarter results. [ID:nN26218439]

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 U.S. attorney in Philadelphia on the matter and had set aside $520 million as a provision in 2009.

Reporting by Ben Hirschler; Editing by Erica Billingham

for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up