The US Food and Drug Administration (FDA) 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 US FDA's 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 US FDA briefing materials, the sNDA filed by AstraZeneca includes a proposed draft indication based on the JUPITER study. The draft indicates: 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; and 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 US FDA briefing materials, the US 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 US 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 US 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.