Alzheimer’s drugs slammed as ‘ineffective’ in major review, but critics push back
The team recommended that future research should explore other “biological pathways” involved in Alzheimer’s disease.
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“I see Alzheimer’s patients in my clinic every week and I wish I had an effective treatment to offer them,” said senior author Edo Richard, professor of neurology at Radboud University Medical Centre, in the release. “Existing approved drugs offer some benefit for some patients, but there remains a high unmet need for more effective treatments.”
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“Given the absence of correlation between amyloid removal and clinical benefit, we need to explore other pathways to help address this devastating disease.”
Fox News Digital reached out to the study authors for comment.
The Alzheimer’s Association has requested that Cochrane withdraw the analysis, calling it “scientifically flawed” and warning that it could lead to “misguided and potentially harmful conclusions.” The Cochrane analysis is lacking patients’ perspectives, according to the association.
The researchers also identified some potential safety concerns linked to the anti-amyloid drugs, including a higher likelihood of swelling and bleeding in the brain. (Saul Loeb/AFP/Getty Images)
“Many people living with mild cognitive impairment and mild dementia due to Alzheimer’s disease who are using these treatments are taking trips they weren’t sure they’d take, spending joyful time with friends and family, making plans for next month, doing things they love, and staying present in their lives and the lives of the people they care about,” the group said in a statement provided to Fox News Digital.
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The association also pointed to real-world clinical settings where amyloid-targeting monoclonal antibodies have shown efficacy and safety very similar to what was reported in the phase 3 clinical trials — “clinically meaningful slowing of disease progression/cognitive decline with modest side effects.”
“Real-world data, along with clinical trial results, should guide decision-making,” the group added.
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Lilly, maker of donanemab (Kisunla), agreed with the Alzheimer’s Association that the Cochrane review is built on an “inherently flawed methodology.”
“It pools data from across multiple amyloid-targeting therapies as a class, including molecules that did not achieve their clinical trial endpoints and were never granted regulatory approval,” a Lilly spokesperson told Fox News Digital.
Leqembi, the first drug to show that it slows Alzheimer’s, was approved by the U.S. Food and Drug Administration in early January 2023. “The FDA has stated that lecanemab is part of a newer generation of anti-amyloid therapies targeting aggregated amyloid and has learned from previous failures,” a spokesperson for Eisai, the company’s spokesperson, told Fox News Digital. (AP Photos)
“Combining data on unsuccessful molecules with approved medicines artificially dilutes the observed benefit and produces class-level conclusions that do not reflect the evidence for any individual approved therapy.”
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Lilly noted that regulatory authorities around the world have evaluated donanemab’s clinical data “on its own merits,” which is the “appropriate standard for determining benefit and risk for patients.”
Eisai’s, which makes the Alzheimer’s drug lecanemab (Leqembi), echoed these concerns.
“We need to explore other pathways to help address this devastating disease.”
Article source: https://www.foxnews.com/health/alzheimers-drugs-slammed-ineffective-major-review-critics-push-back