The long-awaited drug against Alzheimer’s of the Eli Lilly company was held by US state regulators for further review, the pharmaceutical giant announced on Friday, a blow for patients suffering from the devastating brain disorder.
During a clinical trial, donanemab was found to slow cognitive decline in the early stages of the disease, but also causes a high rate of side effects, including deaths.
The Food and Drug Administration (FDA) “has informed Eli Lilly that it wants to better understand the issues related to the evaluation of the safety and effectiveness of donanemab”the company said in a statement released this Friday.
The regulatory body indicated that it will call a new meeting of experts, without indicating a precise date.
“The timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024,” he pointed out.
“We are confident in the potential of donanemab to offer very significant benefits to people with early symptomatic Alzheimer’s disease”said Anne White, executive vice president of the company.
The FDA’s decision to hold a new meeting was “unexpected”, but “We will work with the FDA and community stakeholders to make that presentation and answer all questions.”
Donanemab is an intravenously injected antibody that targets the buildup of beta-amyloid, a protein found in the brains of many patients with Alzheimer’s, the most common form of dementia.
Another anti-amyloid therapy called Leqembi, developed by Eisai of Japan and Biogen in Massachusetts, gained full FDA approval last July and is now accessible through government health insurance for seniors called Medicare.
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Source: Gestion
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