Experimental Alzheimer’s Drug Gets FDA Advisory Committee Approval: ‘Progress’

An experimental Alzheimer’s disease medicationdonanemab, was approved Monday by a U.S. Food and Drug Administration (FDA) advisory committee.

Donanemab is designed to treat symptoms Alzheimer’s diseaseincluding mild cognitive impairment and mild Alzheimer’s dementia.

At the FDA’s Peripheral and Central Nervous System Advisory Committee hearing held Monday in Maryland, advisors unanimously agreed that the drug’s benefits outweigh the potential risks.

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Although this does not guarantee that the FDA will approve the drug, the agency generally follows the panel’s recommendations, according to reports.

Officials from Eli Lilly, the Indiana pharmaceutical company that makes donanemab, were also on hand, answering the committee’s questions about potential side effects.

An experimental Alzheimer’s disease drug, donanemab, was approved Monday by a U.S. Food and Drug Administration advisory committee. (iStock)

At Monday’s hearing, Eli Lilly officials presented clinical trial results which showed that the drug slowed cognitive and functional decline in people with mild cognitive impairment due to the early stages of Alzheimer’s disease.

The study was also published by the Journal of the American Medical Association.

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In phase 3 trials published in May 2023, donanemab was shown to “significantly slow cognitive and functional decline in people with early symptoms of Alzheimer’s disease,” according to a press release posted on the website Eli Lilly’s Internet.

If donanemab is approved, it will become only the second available drug designed to slow the progression of Alzheimer’s symptoms.

Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia. (iStock)

Leqembi, the first new Alzheimer’s treatment in 20 years, received full FDA approval in July 2023.

Donanemab works by removing amyloid built up in the brain. This has been shown to cause side effects such as “brain swelling and tiny bleeding,” researchers found.

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The Chicago-based Alzheimer’s Association released a statement welcoming the FDA’s finding that donanemab is effective for the treatment of early-onset Alzheimer’s disease.

“A future with more approved Alzheimer’s treatments is tremendous progress for people eligible for these medications,” said Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, in a statement provided to Fox NewsDigital.

Eli Lilly officials presented clinical trial results showing that the drug, donanemab, slowed cognitive and functional decline in people with mild cognitive impairment due to the early stages of Alzheimer’s disease. (iStock)

“Advances are being made in treatment. We now need more types of treatments, targeting a variety…

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