FDA approves Biogen's Alzheimer's drug despite lack of evidence

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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."

More..

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

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1. More details

The FDA approved aducanumab to treat people with mild cases of cognitive impairment or dementia whose brains have accumulated beta amyloid, a sticky substance that many researchers believe plays a significant role in Alzheimer’s disease for many patients.

Aducanumab works by clearing amyloid from the brain.

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Before prescribing it, doctors will want to first make sure their patient’s brain has amyloid buildup, which typically requires an imaging scan or spinal tap that usually aren’t covered by medical insurance, Dr. Isaacson (who is also a paid consultant to the company) said. Unlike other Alzheimer’s drugs delivered in pills that can be picked up at a pharmacy, aducanumab requires monthly infusions at a clinic. Patients will require monitoring with magnetic resonance imaging, or an MRI, to guard against small brain bleeds, a potential side effect of the drug, Dr. Isaacson said.

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Cigna will likely cover the drug for people who match the patients studied in Biogen’s clinical trials—those with early-stage Alzheimer’s and amyloid buildup in their brains—said Steve Miller, Cigna’s chief clinical officer. Most Alzheimer’s patients are covered by Medicare, and their out-of-pocket costs could be significant, depending on their coverage, because of so-called coinsurance payments that require patients to cover a percentage of certain health costs, Dr. Miller said.

Cigna estimates that patients with traditional Medicare insurance could be on the hook for more than $10,000 a year in coinsurance and copayments for the drug and amyloid testing, Dr. Miller said. Additional costs for people with supplemental Medigap insurance or commercial coverage through Medicare Advantage could reach up to $4,000 annually.

More..

https://www.wsj.com/articles/first-alzheimers-drug-to-slow-disease-is-approved-by-fda-11623078912 (subscription)