Advisory Committee Briefing Materials For Crestor sNDA Available On US FDA Web Site

Friday, 11 December 2009

The US Food and Drug Administration (FDA) today posted briefing materials in advance of 15 December 2009 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca. The briefing materials can be found on the FDA web site.

In July, AstraZeneca announced that it had filed an sNDA with the FDA which seeks to incorporate outcomes data from the JUPITER study into the CRESTOR (rosuvastatin calcium) Prescribing Information. As noted in the FDA briefing materials, the sNDA filed by AstraZeneca includes a proposed draft indication based on the JUPITER study as follows:

“For the prevention of cardiovascular disease in adult patients with an increased risk of cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, CRESTOR is indicated to:

• reduce the risk of total mortality
• reduce the risk of cardiovascular death
• reduce the risk of stroke
• reduce the risk of myocardial infarction
• reduce the risk of arterial revascularization
• reduce the risk of unstable angina”

Although included in the FDA briefing materials, the Advisory Committee is not expected to vote on the indication proposed by AstraZeneca.

According to the FDA briefing materials, the FDA Advisory Committee will vote on whether there is sufficient evidence of a favourable benefit-to-risk profile for rosuvastatin for the primary prevention of CVD in middle and older aged low-to-moderate cardiovascular disease (CVD) risk individuals with levels of LDL-C <130 mg/dL and hsCRP ≥ 2 mg/L. The FDA Advisory Committee will also discuss three non-voting questions related to imbalances in gastrointestinal-related deaths and confusional state as well as the investigator-reported diabetes as observed in JUPITER.

AstraZeneca looks forward to presenting and discussing the data on 15 December and to continuing to work with the FDA to progress the sNDA towards the approval of an indication that supports the appropriate use of CRESTOR on the basis of this data.

In adults, CRESTOR is prescribed along with diet for lowering high cholesterol. CRESTOR is also prescribed along with diet to slow the progression of atherosclerosis (the build-up of plaque in arteries) as part of a treatment plan to lower cholesterol to goal. The approved US indications are not scheduled to be part of the discussion at the upcoming meeting.


Results from the primary analysis of JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), originally presented in November 2008 at the American Heart Association’s Annual Scientific Sessions and published by the New England Journal of Medicine, evaluated the impact of rosuvastatin 20 mg on reducing CV events (combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes).

JUPITER was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of myocardial infarction, stroke and other cardiovascular events in patients with LDL-C < 130 mg/dL but at increased cardiovascular risk as identified by age and elevated high-sensitivity C-reactive protein (hsCRP). The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.

JUPITER is a part of AstraZeneca’s extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 65,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY programme.

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:


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