AstraZeneca PLC (AZN) Friday said its cholesterol-lowering drug Crestor has been approved in the U.S. for the treatment of atherosclerosis, a move that could help further diversify the product.
The world's sixth-largest drugmaker by prescription drug sales said in a statement that the U.S. Food and Drug Administration has approved Crestor, or rosuvastatin calcium, as an adjunct to diet, to slow the progression of atherosclerosis in patients with elevated cholesterol.
Atherosclerosis is the progressive buildup of plaque - the fatty deposits and other cells - in the inner walls of the arteries.
"This new indication gives Crestor an important differentiator from competitors in the cholesterol-lowering marketplace," the company said.
The package submitted to the FDA which led to the regulatory green light for the drug's new usage was based mainly on a study called Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin, which measured effects of Crestor on plaque buildup in the arteries using carotid intima-media thickness. The company said the results showed a slowing of progression of atherosclerosis in people with early signs of the disease, elevated LDL cholesterol, and low cardiovascular risk, who took Crestor.
Last year, Crestor was AstraZeneca's third-largest drug, with sales of over $2 billion. In the third quarter of this year sales of the drug grew 25% to $691 million.
Like other major pharmaceutical companies, AstraZeneca is facing patent challenges from generic drugmakers and pricing pressures from cheaper versions of its older products.
AstraZeneca shares Thursday ended down 2.5% at 2,180 pence in a lower London market, producing a 31% fall year-on-year.