AstraZeneca Receives European Approval For Crestor

Reportedly, the approval is based on the on subgroup data from 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 reduction in the combined endpoint of heart attacks, strokes and CV deaths amongst the high risk patients within Jupiter.

Jupiter was a long-term, randomised, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20mg decreased the risk of heart attack, stroke and other cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by age and elevated high-sensitivity C-reactive protein (hsCRP).

Jupiter is a part of AstraZeneca’s extensive Galaxy clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 65,000 patients have been recruited from 55 countries worldwide to participate in the Galaxy Programme.

Michael Cressman, executive director of clinical research for Crestor at AstraZeneca, said: “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. 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.”