FDA approves Biogen's Alzheimer's drug despite lack of evidence [View all]

The FDA has approved Biogen's Alzheimer's drug, aducanumab, which will be marketed as Aduhelm.

Why it matters: Aduhelm is the first federally approved Alzheimer's treatment in roughly 18 years, but there is no conclusive evidence the drug slows the decline of memory and brain function.

The background: Two years ago, Biogen halted two clinical trials of aducanumab.

But the company looked again at the clinical trial data and argued one of the failed trials suggested some benefit for Alzheimer's patients on a higher dose of the drug. The other trial still failed.

The FDA generally wants "two adequate and well-controlled trials" for drug approval, although it does on rare occasions consider one well-controlled trial with "confirmatory evidence."

Biogen applied for FDA approval last summer.

Independent physicians, statisticians, drug researchers and others in the field urged the FDA to reject the drug, warning the study supporting aducanumab is small, flawed and possibly a false positive. Side effects like brain swelling have also raised concerns.

The FDA's statistical reviewer of aducanumab said there was "no compelling substantial evidence of treatment effect or disease slowing and that another study is needed."

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https://news.yahoo.com/fda-approves-biogens-alzheimers-drug-150205985.html