AstraZeneca has received US Food and Drug Administration (US FDA) approval for Crestor (rosuvastatin calcium). The drug is prescribed to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).
The US FDA approval was based on data from the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study which evaluated the impact of Crestor 20 mg on reducing major cardiovascular events in a previously unstudied population.
JUPITER is 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 Programme.
In JUPITER, Crestor significantly reduced the relative risk of heart attack by 54% stroke by 48% and arterial revascularization by 46% versus placebo.
“Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication. This new indication adds to the body of evidence physicians use to evaluate Crestor as a treatment option,” said Dr Howard Hutchinson, chief medical officer, AstraZeneca.
In India, AstraZeneca launched Crestor 5, 10, 20 and 40 mg tablets in April 2009. The introduction is especially significant as current projections suggest that by the year 2020 India will have the largest cardiovascular disease burden in the world and account for one third of all deaths, with one fifth of the deaths in India resulting from coronary heart disease. Sadly, many of these deaths will be among young Indians, also because heart disease in India occurs 8 to 10 years earlier than in the West. Even women are prone to the risk as one in four women in urban India and every eighth woman in rural India is suffering from high cholesterol.
Results from JUPITER were originally presented in November 2008 at the American Heart Association’s Annual Scientific Sessions, and published in the New England Journal of Medicine.