FDA Backs Crestor's Wider Use - Analyst Blog

AstraZeneca (AZN) received a positive opinion from the US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) regarding the expanded use of Crestor. AstraZeneca is seeking approval for Crestor to treat patients with normal cholesterol levels but having other risks of heart disease. The committee voted 12-4 in favor of Crestor after analyzing its benefit against possible risk in some patients. However, the committee was concerned that Crestor should not be used at random in patients with low risk.

Following the recommendation, AstraZeneca has moved one step closer to FDA approval. Although the FDA is not required to follow the committee’s opinion, it generally does so.

The panel’s recommendation was based on data presented from the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study conducted with 18,000 patients. It was observed that Crestor lowered deaths, heart attacks and strokes in middle-aged people (above 50 years) with normal cholesterol level having heart disease.

Crestor is one of AstraZeneca’s key drugs logging sales of about $3.6 billion last year. 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 that smooth since Pfizer’s (PFE) Lipitor will lose patent exclusivity in 2011. This will increase competition in the cholesterol-lowering market with the entry of generics.

In addition, AstraZeneca is tied in litigation with seven generic drug companies including Mylan Laboratories (MYL), Sandoz, the generics arm of Novartis (NVS) and Apotex, among others who have challenged Crestor’s patent. The trial is likely to begin in Feb. 2010.

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