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Advisory Committee Recommends the Use of Rosuvastatin to Reduce the Risk of Cardiovascular Events
- Men > 50 years, women > 60 years;
- Fasting LDL > 2.0 mg/L; Triglycerides No prior history of cardiovascular or cerebrovascular events or coronary heart disease (CHD) risk equivalent as defined by NCEP ATP-III guidelines.
"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.