|Crestor, or rosuvastatin, in 3D.
The FDA has approved AstraZeneca’s Crestor (rosuvastatin calcium) to treat hardening of the arteries, a precursor to the progression of plaque buildup in patients with elevated cholesterol.
The pharmaceutical company said that the FDA’s decision was based largely on the results of Measuring Effects on intima-media Thickness: an Evaluation Of Rosuvastatin (METEOR) study. The trial measured the effects of Crestor on plaque build-up in the arteries using carotid intima-media thickness and demonstrated a slowing of progression of atherosclerosis in patients with early signs of the atherosclerosis, elevated LDL cholesterol, and low cardiovascular risk.
The approval means that the drug, which currently has sales of approximately $2 billion (£958 million) annually, can be marketed more widely.
Last week, the London-based AstraZeneca revealed that Cobalt Pharmaceuticals, a Mississauga, Ontario-based generic drug maker, has filed with the FDA to sell cheaper copies of Crestor. AstraZeneca said it would challenge Cobalt’s generic application.