The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) today voted 12 yes, 4 no, and 1 abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of CRESTOR® (rosuvastatin calcium) in individuals meeting the following criteria:
- Men greater than or equal to 50 years, women greater than or equal to 60 years;
- Fasting LDL < 130 mg/dL; hsCRP greater than or equal to 2.0 mg/L; Triglycerides <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.
The review, based on results of the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study, is part of the FDA's evaluation of the supplemental New Drug Application (sNDA) filed by AstraZeneca in April 2009 to update the CRESTOR Prescribing Information with information about the impact of CRESTOR on reducing the risk of cardiovascular events.
"AstraZeneca welcomes the Advisory Committee's positive vote," said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca. "Today's discussions will help guide our ongoing dialogue with the FDA regarding our request for an indication that supports the use of CRESTOR for the prevention of cardiovascular disease in patients with an increased risk of experiencing 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.
The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and opinions on clinical matters. 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.