New indication in USA for AstraZeneca's Crestor

Anglo-Swedish drug major AstraZeneca has received US Food and Drug Administration approval of a new indication for its blockbuster cholesterol-reducing drug Crestor (rosuvastatin), that of its use as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.

Crestor had sales of around $2.0 billion in 2006 and generated global turnover of $691.0 million in the third quarter of this year, with US revenues standing at $342.0 million (Marketletter November 12). However, analysts at Lehman Brothers believe that the new claim will have little impact on sale given the tough market conditions since the advent of the first generic statin, the former Zocor (simvastatin). Crestor is licensed from Japanese drugmaker Shionogi.

The submission package to the FDA was based largely on the results of a pivotal study called METEOR (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin) which 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 people with early signs of the disease, elevated low-density lipoprotein cholesterol, and low cardiovascular risk, taking Crestor 40mg.