AstraZeneca (AZN) has landed an expanded label for the cholesterol-lowering medication Crestor, allowing doctors to use the statin therapy to treat a huge new group of patients. The new group, potentially numbering in the millions, includes people who are at an increased risk of heart disease, but have not been diagnosed with it. That group includes people with high levels of C-reactive protein and at least one other risk factor for stroke or heart attack, such as smoking, high blood pressure, a family history of premature heart disease.
It's also the first time Crestor has been approved for use to help prevent heart disease in people with “normal” low-density lipoprotein cholesterol levels who show no clinical evidence of heart disease, says the US Food and Drug Administration.
Broader approved usage could translate into big 2010 sales of Crestor. Already, 2009 sales were up to $3.6 billion, a 29 percent increase compared to 2008. But how much of a market advantage AstraZeneca will accrue in the years ahead remains unclear. Cheaper generic statins, such as a copy of Pfizer's (PFE) rival Lipitor, are well on their way to market and may arrive as early as late 2011.
Combined sales of lipid regulators in the United States during 2008 reached $14.5 billion, according to IMS Health.
The FDA advisory board, which approved the new uses for Crestor, has voiced concern that the approval will lead to Crestor being used too broadly, including in patients at low risk and urged caution among health care professionals interpreting the new indication.
The agency also said that the trial results supporting the new indication “do not support the use of Crestor in all patients with an elevated high sensitivity C-reactive protein.”
The new indication was approved on the basis of a large and long-term study, first published at the end of 2008, which assessed the effect of Crestor on the occurrence of major cardiovascular disease events in more than 17,500 men women who had no clinically evident cardiovascular disease and had low cholesterol.
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