Favorable Vote from FDA Advisory Committee on Benefit/Risk of CRESTOR(R)(rosuvastatin calcium) in JUPITER Study

Wed, 12/16/2009 - 3:48am
TheFDA Endocrinologic and Metabolic Drugs Advisory Committee(EMDAC) has voted 12 yes, 4 no, and 1 abstention that AstraZeneca hasestablished sufficient benefit to offset the observed risks to support the useof CRESTOR (rosuvastatin calcium) in individuals meeting the followingcriteria: -- Men greater than or equal to 50 years, women greater than or equal to60 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 orcoronary heart disease (CHD) risk equivalent as defined by NCEPATP-III guidelines. The review, based on results of the JUPITER (Justification for the Use ofstatins 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 PrescribingInformation with information about the impact of CRESTOR on reducing the riskof cardiovascular events. "AstraZeneca welcomes the Advisory Committee's positive vote," said HowardHutchinson, M.D., Chief Medical Officer, AstraZeneca. "Today's discussionswill help guide our ongoing dialogue with the FDA regarding our request for anindication that supports the use of CRESTOR for the prevention ofcardiovascular disease in patients with an increased risk of experiencingcardiovascular events." The FDA Advisory Committee also discussed four non-voting items related toa range of other observations in JUPITER, including adverse events and whetherthe JUPITER trial identified an appropriate new target patient population.The FDA frequently convenes advisory committee meetings to obtainindependent expert guidance and opinions on clinical matters. While the FDAis not required to follow this guidance, the agency usually takes the adviceinto consideration when rendering its final decisions on pending applicationsand other public health matters.

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