FDA Delays Approval of New Alzheimer’s Drug

Eli Lilly logo | Photo by Cristina Arias/Cover/Getty Images

Federal approval of Eli Lilly and Company’s latest drug to treat Alzheimer’s disease appears to be on pause after regulators called for a committee to further evaluate its safety and efficacy.

The drug, known as donanemab, purportedly works to stall the progression of the disease, yet it has been slow to come to market due to hesitancy on the part of the U.S. Food and Drug Administration (FDA).

Donanemab functions by clearing amyloid plaques from the brains of Alzheimer’s patients and has already shown success in treating those under the age of 75, as covered by The Dallas Express. Yet clinical trials did show that alongside the significant slowing of clinical and functional decline, there was a significant risk of brain swelling. In 1.6% of subjects, the side effect was serious and life-threatening.

Citing insufficient favorable evidence of experimental drug treatment, the FDA denied a request for donanemab’s accelerated approval at the start of last year, as previously reported by The Dallas Express.

The drug’s latest phase 3 randomized, double-blind, placebo-controlled trial, conducted with over 1,736 participants between the ages of 60 and 85 in July of last year, evaluated the drug’s safety and efficacy and demonstrated more positive results in slowing the progression of Alzheimer’s.

Eli Lilly announced this month that the FDA will convene a “Peripheral and Central Nervous System Drugs Advisory Committee” meeting to discuss its latest results. It explained that the FDA wished to gain more information on the safety and efficacy of the drug as well as data on its “limited-duration dosing regimen,” according to a press release.

Although no exact date for the meeting has been released, approval of the drug is expected to be delayed beyond the first quarter of the year, beyond the initially expected approval date of early 2024.

While Eli Lilly’s executive vice president, Anne White, called the FDA’s move to convene an advisory committee “unexpected,” she expressed satisfaction in it providing an “opportunity” to demonstrate donanemab’s efficacy and safety.

“We are confident in donanemab’s potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease,” she said in the release.

Alzheimer’s is the most common cause of dementia in the United States, where over 6 million Americans aged 65 and older are believed to have it. Like many disorders affecting the brain, obesity heightens the risk of this disease, as previously reported by The Dallas Express.

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