AstraZeneca gets new indication for Crestor in EU to prevent major CV events; agrees to pay $520 million to settle US Seroquel marketing case

Anglo-Swedish drug major AstraZeneca's cholesterol lowerer Crestor (rosuvastatin) has been approved in 19 countries within the European Union for the prevention of major cardiovascular events in patients who are at high risk of having a first cardiovascular event, the company announced this morning.

This new indication is based on subgroup data from the landmark JUPITER study, which evaluated the impact of rosuvastatin 20mg on reducing major cardiovascular events in a previously unstudied population. A post-hoc analysis of this subgroup data showed a significant reduction in the combined endpoint of heart attacks, strokes and CV deaths amongst the high risk patients within JUPITER.

'This new indication is a significant milestone and means that rosuvastatin can now be prescribed to high risk patients to prevent CV events including heart attacks and strokes,' said Michael Cressman, executive director of clinical research for Crestor, adding: 'Clinical studies have previously shown that rosuvastatin was the most effective statin at lowering LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.'