{"id":587,"date":"2024-03-09T11:51:03","date_gmt":"2024-03-09T11:51:03","guid":{"rendered":"https:\/\/retirednurseblog.com\/index.php\/2024\/03\/09\/eli-lilly-says-alzheimers-drug-approval-delayed-as-fda-seeks-input-from-advisers\/"},"modified":"2024-03-09T11:51:03","modified_gmt":"2024-03-09T11:51:03","slug":"eli-lilly-says-alzheimers-drug-approval-delayed-as-fda-seeks-input-from-advisers","status":"publish","type":"post","link":"https:\/\/retirednurseblog.com\/index.php\/2024\/03\/09\/eli-lilly-says-alzheimers-drug-approval-delayed-as-fda-seeks-input-from-advisers\/","title":{"rendered":"Eli Lilly says Alzheimer\u2019s drug approval delayed as FDA seeks input from advisers"},"content":{"rendered":"
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Drugmaker Eli Lilly says that approval of its experimental Alzheimer\u2019s medication donanemab will be delayed beyond the end of March as the US Food and Drug Administration plans to call a last-minute meeting of its outside advisers to review the drug\u2019s safety and efficacy. <\/p>\n

The medicine had been expected to be cleared by the end of the first quarter of this year, after being pushed back already from an expected approval last year. It would follow Eisai and Biogen\u2019s Leqembi to market as the second drug shown to slow the course of the memory-robbing disease, which affects more than 6 million Americans. Both drugs work by targeting plaque buildups in the brain that are known as amyloid. <\/p>\n

The FDA told Lilly that it plans to call the advisory meeting to discuss the safety of donanemab, as well as the design of a key clinical trial supporting its application, called Trailblazer-Alz 2, the company said in a news release Friday. The date for the meeting hasn\u2019t been set, Lilly said. <\/p>\n

\u201cWe are confident in donanemab\u2019s potential to offer very meaningful benefits to people with early symptomatic Alzheimer\u2019s disease,\u201d Lilly Neuroscience President Anne White said in the release. \u201cIt was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the Trailblazer-Alz 2 results and put donanemab\u2019s strong efficacy in the context of safety.\u201d <\/p>\n

The main safety concerns with these medicines are brain swelling and micro-hemorrhages known as amyloid-related imaging abnormalities, or ARIA. In donanemab\u2019s Phase 3 clinical trial, 37% of participants had ARIA, including three who died. <\/p>\n

Leqembi has been\u00a0tied\u00a0to patient deaths as well, although its rate of ARIA was lower in\u00a0trials. <\/p>\n

Lilly said the FDA also wanted its outside experts to weigh in on the \u201cunique trial design\u201d of the donanemab study, which allowed patients to stop taking the drug once the amyloid plaques were shown to be cleared from the brain. Other Alzheimer\u2019s drugs, including Leqembi, don\u2019t have designated stopping points. <\/p>\n

The trial was also different in that it separated patients into groups based on their levels of another Alzheimer\u2019s-related protein called tau. It found that among participants characterized as having \u201cintermediate\u201d levels of tau, those taking donanemab had a 35% slower decline in the ability to think clearly and perform daily tasks compared with those taking a placebo. <\/p>\n

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