Astra wins EU approval for Crestor
DRUGS giant AstraZeneca yesterday won European approval to promote anti-cholesterol drug Crestor, which aids in the fight against heart disease.
The decision to approve the new use of the product 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 plus at least one other risk factor.
Wider approval for Crestor is likely to boost sales of the drug, but 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.
Meanwhile, AstraZeneca looks set to settle a US federal investigation into its marketing practices for the antipsychotic drug Seroquel this week for $520m (£339m).
The New York Times newspaper reported that the US Justice Department would disclose details of the agreement today, ahead of AstraZeneca announcing its first-quarter results statement due to be published tomorrow.