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Advisory Committee Briefing Materials for CRESTOR(R) sNDA Available on US FDA Web Site
Date:12/11/2009

WILMINGTON, Del., Dec. 11 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) posted briefing materials in advance of the December 15(th) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca ( AZN). The briefing materials can be found on the FDA web site.

(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO )

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 favorable
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SOURCE AstraZeneca
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