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After a lengthy examination of the file, the eleven members of the commission decided, with ten votes against and one abstention, that the treatment had not proved sufficiently effective. The committee’s opinion is not binding, but the FDA usually follows its recommendations.
No drugs have been licensed for Alzheimer’s for nearly two decades, and treatment studies have failed in recent years.
Biogen Laboratories hoped to be the first to receive the green light to treat the cognitive decline suffered by Alzheimer’s patients. So far there is no cure.
“I think there is a huge, urgent and unmet need for Alzheimer’s treatment. I also think that if we back something up with poor data, the risk is that treatment will be delayed for many years in terms of quality and efficiency,” he explained. Joel Perlmutter, one of the committee’s experts.
One large clinical study concluded that the Biogen Laboratories drug was effective, while another tested negative.
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