AstraZeneca drug set for EU approval
AstraZeneca's vital new cholesterol-lowering drug Crestor was granted approval for launch in the Netherlands yesterday, paving the way for regulatory approval throughout the European Union.
The news was a useful fillip for the company, which has been under pressure on Crestor after US authorities refused to approve high doses of the drug and ordered additional clinical trials. It was also the highlight of yesterday's bullish annual business review for investors and analysts, which sent AstraZeneca's shares up 3 per cent to 2,338p.
Crestor is expected to have sales of up to £4bn, but some analysts expressed concern over comments that AstraZeneca will spend "whatever it takes" to market the drug when it reaches the crowded US market late next year.
The European approval, which includes the high dose that is disputed in the US, helped ease concerns over the drug's safety.
AstraZeneca also moved yesterday to quell fears over the safety of its lung cancer drug Iressa. It said an influential committee of advisers to the US Food & Drug Administration had decided not to re-examine the safety of Iressa at its next meeting, as had been feared.
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