FDA OKs wider use of AstraZeneca’s Crestor

Shares in AstraZeneca are on the rise this morning after US regulators gave the go-ahead for wider use of its blockbuster Crestor and allow it to be marketed as a preventative treatment for people who have normal or slightly elevated cholesterol levels.

The US Food and Drug Administration has approved Crestor (rosuvastatin) to reduce the risk of stroke, myocardial infarction and arterial revascularisation procedures in individuals without clinically evident coronary heart disease. However, patients newly-eligible for the drug will have an increased risk of cardiovascular disease based on age (men aged 50 and women 60), elevated high-sensitivity levels C-reactive protein and the presence “of at least one additional CVD risk factor”, such as hypertension or smoking.

The approval is based on the landmark 17,802–patient Jupiter study which revealed that Crestor significantly reduced the relative risk of heart attack by 54%, stroke by 48% and arterial revascularisation by 46% versus placebo. The green light was expected given that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 12 yes, four no, and one abstention in December that the benefits of Crestor offset its risks in the aforementioned group of patients.

Howard Hutchinson, AstraZeneca’s chief medical officer, said the approval is a significant milestone for the firm and “this new indication adds to the significant body of evidence physicians use to evaluate Crestor as a treatment option.” Sales of the drug could now soar, although some analysts believe that rise could be tempered by the introduction in the USA of generic copies of Pfizer’s rival drug Lipitor (atorvastatin) in 2011.

Investors are impressed, however, and AstraZeneca’s shares were already up 1.6% this morning at 9am (UK time) at £28.24.