AstraZeneca shares jump on FDA approval

AstraZeneca shares jumped as much as 5 per cent today after a US regulatory panel backed its new cholesterol fighter drug Crestor…

AstraZeneca shares jumped as much as 5 per cent today after a US regulatory panel backed its new cholesterol fighter drug Crestor.

The Food and Drug Administration (FDA) advisory panel voted unanimously in support of approving the medicine in doses from five to 40 milligrams.

There had been fears the experts might baulk at the highest dose due to potential side effects. In the event, the panel backed the full dose range, although it said patients on 40 mg should be carefully watched.

The FDA generally follows the advice of its panels and the drug watchdog is expected to decide by August 12th whether to approve Crestor, which industry analysts believe could generate peak sales of $3 billion worldwide.

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Mr Andrew Baum, analyst at Morgan Stanley, said the positive review boded well for Crestor's label, which will be crucial if AstraZeneca is to win a significant share of the market for so-called statin drugs in the United States.

AstraZeneca Mr Tom McKillop has said in the past Crestor, which is on sale in some European countries and Canada, can take 20 per cent of a global statin market worth $19 billion a year. The market is dominated by Pfizer's Lipitor, the world's top-selling drug with $8 billion in annual sales.