December 16th, 2009
FDA Advisers Recommend Expanding Crestor to Patients Without High Cholesterol
Larry Husten, PHD
An FDA advisory panel voted 12 to 4 on Tuesday to expand the use of rosuvastatin (Crestor) to patients with normal cholesterol levels and no history of cardiac disease, according to the Associated Press.
The panel’s recommendation was based on last year’s JUPITER trial, in which rosuvastatin cut cardiovascular risk in patients with normal LDL cholesterol but high C-reactive protein levels.
The manufacturer said it “would focus on marketing the drug to patients with health issues that put them at increased risk of heart problems, such as a smoking habit or family history of hypertension,” the AP reports.
The FDA is expected to make its decision in early 2010.