FDA AdCom favourable vote on

RNS Number : 1850E

AstraZeneca PLC

16 December 2009

 



FAVOURABLE VOTE FROM FDA ADVISORY COMMITTEE ON 
BENEFIT/RISK OF CRESTOR IN JUPITER STUDY

On 15 December 2009, the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) 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 ≥ 50 years, women ≥ 60 years; 

• Fasting LDL < 130 mg/dL; hsCRP ≥ 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.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com

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16 December 2009

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