FDA REJECTS BIOGEN’S ALZHEIMER’S DRUG ON LACK OF EVIDENCE

Highlights
• The panel of outside experts agreed that a pivotal study in patients failed to show substantial evidence on effectiveness of the drug
• This experimental drug was developed by Biogen and called as aducanumab, which doesn’t cure or reverse Alzheimer’s but slows the rate of decline
• Out of 11 panelists, eight voted against the drug citing it failed to show strong evidence, while one voted in its favor and two said they were undecided

The panel of outside experts for the Food and Drug Administration has rejected a closely watched Alzheimer’s drug on Friday saying there wasn’t enough evidence that the experimental drug slowed the brain-destroying disease.
The panel agreed that a pivotal study in patients failed to show substantial evidence on effectiveness of the drug. They also warned of multiple red flags with the data, which did not initially show any benefit until another analysis with later results.
Dr. Joel Perlmutter, of Washington University School of Medicine, a member of the FDA panel said “Alzheimer’s treatment is a huge, urgent, unmet need, but if we approve something with data that is not strong we have the risk of delaying good, effective treatments.”
Out of 11 panelists, eight voted against the drug citing it failed to show strong evidence, while one voted in its favor and two said they were undecided.
This experimental drug was developed by Biogen and called as aducanumab, which doesn’t cure or reverse Alzheimer’s but slows the rate of decline.

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