Crestor gains prevention licence in Europe
pharmafile | April 27, 2010 | News story | Sales and Marketing | AstraZeneca, Crestor, statin
AstraZeneca’s statin treatment Crestor has been approved in the European Union for the prevention of major cardiovascular events in patients who are at high risk of having a first heart attack or stroke.
The licence will provide a major sales opportunity for the blockbuster drug, which has enjoyed continued strong growth in recent years.
The new indication is based on subgroup data from the major JUPITER study, which evaluated Crestor (rosuvastatin) 20mg in 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 cardiovascular deaths among 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 cardiovascular events including heart attacks and strokes,” said Michael Cressman, executive director of clinical research for Crestor.
“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.”
In JUPITER, Crestor 20mg was well tolerated in nearly 9,000 patients. There was no difference between treatment groups for major adverse events. There was a small increase in diabetes as reported by doctors, which AstraZeneca says is in line with data from other large placebo controlled statin trials.
High risk patients defined as having a SCORE risk greater than or equal to 5% or Framingham Risk > 20 per cent.
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