Label expansion for blockbuster Crestor

Crestor (rosuvastatin), AstraZeneca's (AZ) blockbuster 'superstatin', has been approved in 19 EU countries to prevent major cardiovascular events in patients at high risk of a first event. Patients are classified as high risk if they have a SCORE (Systematic Coronary Risk Evaluation) of 5 per cent or higher, or a Framingham Risk of more than 20 per cent.

This new indication has been granted in light of a post-hoc analysis of subgroup data from the JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) study, part of the GALAXY clinical trial programme.

The JUPITER study treated almost 18,000 patients in 26 countries and in March 2008 was closed ahead of schedule due to unequivocal evidence of benefit of Crestor over placebo.

The analysis of JUPITER data showed that high risk patients treated with 20mg Crestor experienced a significant reduction in the incidence of heart attacks, strokes and cardiovascular deaths compared with those treated with placebo, with no difference between treatment groups in terms of major adverse events.

In studies, patients treated with Crestor have experienced a small increase in the incidence of physician-reported diabetes, and the summary of product characteristics (SmPC) has now been updated to reflect this.

Crestor has been approved in more than 100 countries worldwide for the treatment of high levels of low-density lipoprotein (LDL) cholesterol and/or triglycerides since 2003, and has now treated more than 19m patients globally. In February 2010, the US Food and Drug Administration (FDA) approved Crestor for the prevention of cardiovascular disease in patients with normal levels of cholesterol but high levels of C-reactive protein and at least one other risk factor.

AZ is currently awaiting judgment in a trial regarding the validity of its patent for Crestor, following legal challenges from a group of generics manufacturers. Currently the patent is scheduled to expire in 2016, and Thomson Reuters anticipates that sales of Crestor will rise to $6.5bn in 2013.