Label Expansion for AZN Drug

AstraZeneca (AZN - Analyst Report) received approval from the US Food and Drug Administration (FDA) for expanded use of one of its key drugs, Crestor (rosuvastatin calcium). The drug can be used to treat patients with normal cholesterol levels but with increased risk of cardiovascular disease. 

In December 2009, Crestor received a positive opinion from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The committee voted 12-4 in favor of the drug after analyzing its benefits in some patients. However, they were concerned about the drug’s use on patients with low risk.
 
The FDA approval was based on data presented from the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study conducted on 17,802 patients. It was observed that Crestor lowered deaths, heart attacks and strokes in middle-aged people (above 50 years) with normal cholesterol level suffering from heart disease.

Crestor is one of AstraZeneca’s key drugs having logged sales of about $4.5 billion in 2009. During the fourth quarter of 2009, total prescriptions for Crestor increased 20% compared with 4% for the overall statin market. In addition, its share of total prescriptions continued to increase to 11.3%.

The FDA approval is likely to increase the targeted patient population which in turn should boost sales. Wider application means Crestor will be able to target about 6.5 million new patients who were not taking cholesterol lowering drugs. However, the future growth trajectory of Crestor may not be as smooth since Pfizer’s (PFE - Analyst Report) Lipitor will lose patent exclusivity in 2011. Thus, the entry of generics will increase competition in the cholesterol lowering market.

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