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FDA: 'Crestor just as safe'

The Food and Drug Administration has concluded that Crestor is just as safe as any other lipid-lowering statin currently marketed.

A welcome break for AstraZeneca (AZ), which has been plagued by regulatory disappointments in recent months, arrived last week in the form of a Food and Drug Administration verdict that Crestor is just as safe as any other lipid-lowering statin currently marketed.

Despite warnings to doctors in the US that certain patient populations taking Crestor may run a higher risk of suffering serious muscle damage (rhabdomyolysis) ñ including Asian Amercians and patients on cyclosporine, or those with severe renal insufficiency ñ the FDA's pronouncement resolves long-standing ambiguity over the relative safety of the drug.

Late last year, US consumer watchdog, Public Citizen, claimed that Crestor (rosuvastatin) was 75 times more likely to cause serious side effects that any of its rivals. However, AZ fiercely contested the claims and the FDA has now been clear that ìbased on the review of the available data from controlled trials, [the] FDA cannot confirm that recommended doses of statins, including Crestor, can cause or worsen kidney failureî.

'Patients taking recommended doses of Crestor have a similar risk of rhabdomyolysis as patients on other statin cholesterol treatments,' it noted in a statement.

The FDA also released a public health advisory, a patient information sheet and a corresponding healthcare professional information sheet, explaining the identified risks and benefits of Crestor.

Following talks with the agency, AZ amended the package insert to ìre-emphasiseî recommendations made in the original label for doctors to use lower starting doses in some patients, as the dose is a key factor in its safety. The label carries a warning of the risks linked to the highest 40mg dose, and recommends that high risk patients be started on the lowest dose, 5mg.

`The FDA will continue to carefully evaluate the scientific data on Crestor and the other statin drugs and, when appropriate, modify the drug label(s) in a timely fashion,î the FDA added.

Yet, the delay in reaching the status quo had a negative impact on the product's sales growth, with some analysts cropping initial expectations of a potential $3bn product by some margin.

The drug is still expected to sell well once momentum for it has gathered and following the FDA's announcement last week, AZ became the highest climber in the FTSE100.

30th September 2008

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