AZ receives FDA approval for Crestor

AstraZeneca's new statin Crestor (rosuvastatin calcium) has been approved by the US FDA as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.

Crestor is the newest member of the cholesterol-lowering statin (HMG-CoA reductase inhibitors) class of drug therapy and has been shown not only to lower LDL-cholesterol by up to 63%, but also to provide a significant increase in HDL cholesterol.

The FDA has approved the recommended usual starting dose of Crestor to be 10mg once daily with a dose range of 5-40mg available. For patients with marked hypercholesterolemia (LDL-C >190mg/dL) and aggressive lipid targets, a 20mg start dose may be considered, and for special populations a 5mg dose is also available.

Currently, it is estimated that more than 20 million Americans have an LDL goal of <100mg/dL, and it is estimated that only about one third of treated patients reach their LDL goal. CVD is estimated to account for a third of all deaths globally and is the leading cause of mortality in Europe and the US.

The global statin market is estimated to be worth approximately $20bn and growing at a rate of around 13% annually. Crestor was first approved in the Netherlands in 2002 and has since been approved in 23 other countries. It has been launched in a number of countries, including Canada, the Netherlands and the UK. AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co, the pharmaceutical company that discovered the drug, in April 1998.

'We are delighted with the approval of Crestor in the US,' said Sir Tom McKillop, ceo of AstraZeneca. 'We believe that CRESTOR offers an important new treatment option for patients who are either untreated or not at target cholesterol levels.'