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AstraZeneca's Crestor treatment receives FDA approval for new indication
AstraZeneca (LSE: AZN) said its CRESTOR treatment has been approved for a new indication by the US Food and Drug Administration (FDA), for use in reducing the risk of stroke, heart attack and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).
The FDA approval was based on data from the landmark JUPITER study which evaluated the impact of CRESTOR 20 mg on reducing major cardiovascular (CV) events in a previously unstudied population.
"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", AstraZeneca chief medical officer Howard Hutchinson commented, “This new indication adds to the significant body of evidence physicians use to evaluate CRESTOR as a treatment option".
CRESTOR (rosuvastatin calcium) is indicated an adjunct to diet to reduce elevated bad cholesterol levels and to inclease levels of good cholesterol in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients.
JUPITER stands for ‘Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin’. The study evaluated the effect CRESTOR (rosuvastatin calcium) had on the occurrence of major cardiovascular (CV) disease events in 17,802 people, consisting of men over fifty and women over sixty.
AstraZeneca said that in the JUPITER study, CRESTOR significantly reduced the relative risk of heart attack by 54%, stroke by 48%, and arterial revascularization by 46%.
The JUPITER study is a part of the company’s GALAXY clinical trials programme, which are designed to address important unanswered questions in statin research, AstraZeneca said. Currently, more than 65,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
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