Following similar approval in the U.S, drug firm Astra-Zeneca has won approval from European regulators to market their cholesterol-lowering statin to a far wider group of patients.
This means that in 19 European Union countries, the firm will be able to market the product to a far wider patient group. Industry analysts have said that while approval is likely to result in increased sales of the drug, the upcoming expiry of Pfizer’s patent over statin Lipitor in 2011 may affect that, as it will presage the arrival of cheaper generics on the market.
The ruling means that Crestor can now be prescribed to patients thought to be at risk of a first heart attack. The decision comes after further analysis from the Jupiter study, which involved nearly 18,000 patients. It showed that people with elevated levels of the protein C-reactive benefited from treatment with Crestor and reduced their overall risk of experiencing an event like a heart attack or stroke.
Previously Crestor was approved for use in patients with high levels of the ‘bad’ cholesterol LDL, which is strongly linked to an increased risk of atheroscelerosis. This is when fatty plaques build up in the blood vessels, increasing the risk of blood flow to the heart being blocked.
Michael Cressman, who is the executive director for clinical research at Astra Zenica, described the decision as a ‘significant milestone’.