The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Wednesday voted (12 yes, four no and one abstention) that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of Crestor (rosuvastatin calcium) in more individuals for more conditions.
If the FDA accepts the committee’s recommendation (which is typical), individuals meeting the following criteria would now be indicated to receive the statin:
- Men at least 50 years, women at least 60 years;
- Fasting LDL less than 130 mg/dL; hsCRP at least 2 mg/L; triglycerides less than 500 mg/dL;
- No prior history of cardiovascular or cerebrovascular events or coronary heart disease (CHD) risk equivalent as defined by NCEP ATP-III guidelines.
According to the London-based AstraZeneca, the review, based on results of the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, is part of the FDA's evaluation of the supplemental new drug application, which the company filed in April to update the Crestor prescribing information with information about the impact of Crestor on reducing the risk of cardiovascular events.
The FDA advisory committee also discussed four non-voting items related to a range of other observations in JUPITER, including adverse events and whether the JUPITER trial identified an appropriate new target patient population.
While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.