FDA delays Fabrazyme decision
The US Food and Drug Administration has requested more information withregard to Genzyme's Fabre disease treatment, Fabrazyme (agalsidase alfa), before it will either approve or reject it.
According to a Reuters report, analysts say the decision was not unexpected, and some physicians are concerned that Genzyme's data do not show an improvement in the symptoms of the disease. The company has just demonstrated that there is a decrease in the level of substance which they believe causes the symptoms.
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