--- title: Eli Lilly's Alzheimer’s Drug Donanemab Denied FDA Approval description: In an unexpected setback for the drugmaker, Eli Lilly's bid for accelerated approval of donanemab was rejected by U.S. regulators. canonical: https://time.com/6248904/eli-lilly-fails-early-fda-approval-alzheimers-donanemab/ author: TIME article:opinion: false article:content_tier: free article:published_time: 2023-01-20T18:23:21.000Z article:modified_time: 2026-02-24T15:18:56.578Z article:section: Health og:title: Eli Lilly's Alzheimer’s Drug Donanemab Fails to Get Early FDA Approval og:description: In an unexpected setback for the drugmaker, Eli Lilly & Co.’s bid for accelerated approval of donanemab was rejected by U.S. regulators og:url: https://time.com/6248904/eli-lilly-fails-early-fda-approval-alzheimers-donanemab/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt0dfe71c7f5f5d527/698a39a2457a521371d673ae/eli-lilly-fails-early-fda-approval-alzheimers-donanemab.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 og:image:width: 1024 og:image:height: 576 og:image:alt: Lilly’s Donanemab Fails to Get Early FDA Approval for Alzheimer’s og:type: article twitter:card: summary_large_image twitter:title: Eli Lilly's Alzheimer’s Drug Donanemab Fails to Get Early FDA Approval twitter:description: In an unexpected setback for the drugmaker, Eli Lilly & Co.’s bid for accelerated approval of donanemab was rejected by U.S. regulators twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt0dfe71c7f5f5d527/698a39a2457a521371d673ae/eli-lilly-fails-early-fda-approval-alzheimers-donanemab.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 ---  # Eli Lilly's Alzheimer’s Drug Donanemab Fails to Get Early FDA Approval > Sponsored content. 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Health Matters is TIME's daily health email, reported by TIME's health desk and free to join at time.com/newsletters. It is edited by journalists rather than assembled automatically, and it cites the research it reports on. #### Is Health Matters free? Yes. Health Matters is a free daily newsletter from TIME, available at time.com/newsletters. #### Who reads TIME's Health Matters newsletter? Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. by [Robert Langreth and Nacha Cattan/Bloomberg](https://time.com/author/bloomberg/) ## Robert Langreth and Nacha Cattan/Bloomberg Contributor Jan 20, 2023 6:23 PM UTC  Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain. Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain. Cristina Arias—Cover/Getty Images by [Robert Langreth and Nacha Cattan/Bloomberg](https://time.com/author/bloomberg/) ## Robert Langreth and Nacha Cattan/Bloomberg Contributor Jan 20, 2023 6:23 PM UTC Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy [donanemab](https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-issues-complete-response-0) was rejected by U.S. regulators, an unexpected setback for the drugmaker. The Food and Drug Administration sent the company a complete response letter saying it would not give the early approval for the drug because not enough patients on the trial had received it for a full 12 months, Lilly said Thursday in a statement. The agency wanted Lilly to provide safety data on at least 100 patients who had been on the drug for a year. Lilly’s application for accelerated approval was based on a relatively small mid-stage trial that allowed some patients to stop treatment after about six months. “No other deficiencies were identified,” the company said. **Read More:** [_How My Father’s Brain Helped Develop More Effective Treatment For Alzheimer’s_](https://time.com/6247225/brain-alzheimers-treatment/) The setback won’t affect the company’s 2023 financial guidance or its plans to apply for regular approval for the drug later this year if an ongoing final-stage trial is successful, Lilly said. The company expects those results in the second quarter. Lilly shares fell as much as 1.9% at the New York market open. **Little Sales Impact** Accelerated approval was never expected to lead to significant sales. The U.S. Medicare program has indicated that it won’t broadly cover amyloid-lowering Alzheimer’s drugs like donanemab without full FDA approval. Still, Lilly officials had hoped to gain early approval for the drug. Rival Eisai Co. and partner Biogen Inc. got accelerated approval for their amyloid-lowering drug Leqembi earlier this month, and have already applied for full clearance. “It is an unusual situation,” Lilly Chief Scientific and Medical Officer Daniel Skovronsky said in an interview. The company’s drug was quite effective at removing amyloid in the mid-stage trial, he said. Some patients stopped taking it after a few months because their amyloid levels had fallen so far. Others who responded more slowly continued on it for more than a year. If the drug had been less effective, the company wouldn’t have faced this issue, he said. **Read More:** [_Why It’s Hard to Get the New Alzheimer’s Drug Lecanemab_](https://time.com/6245670/lecanemab-medicare-costs-alzheimers-drug/) Hopes for donanemab had been high after an earlier analysis of the trial showed the drug slowed cognitive decline by 32%. However, participants also had a 39% rate of brain swelling or bleeding compared to 8% of those on a placebo. Meanwhile, Eisai’s Leqembi slowed cognitive and functional decline by 27%. That drug gained FDA accelerated approval based on its ability to lower amyloid. “The priority of course is to get the traditional approval,” said Skovronsky, who didn’t rule out the possibility the company could still go back and seek accelerated approval once it obtained more safety data. “Everything depends on our phase 3 trial.” On Friday, Lilly and Boehringer Ingelheim reported more news from the FDA, saying the regulator accepted a supplemental new drug application for Jardiance. The diabetes drug, one of Lilly’s top sellers, is in testing for reducing the risk of kidney disease progression and heart-related deaths in adult chronic kidney disease patients. _—With assistance from Jonathan Roeder._ ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6248904/eli-lilly-fails-early-fda-approval-alzheimers-donanemab/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6248904/eli-lilly-fails-early-fda-approval-alzheimers-donanemab/"},"headline":"Eli Lilly's Alzheimer’s Drug Donanemab Fails to Get Early FDA Approval","datePublished":"2023-01-20T18:23:21.000Z","dateModified":"2026-02-24T15:18:56.578Z","description":"In an unexpected setback for the drugmaker, Eli Lilly & Co.’s bid for accelerated approval of donanemab was rejected by U.S. regulators.","url":"https://time.com/6248904/eli-lilly-fails-early-fda-approval-alzheimers-donanemab/","keywords":["Drugs","wire","bloomberg wire"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt0dfe71c7f5f5d527/698a39a2457a521371d673ae/eli-lilly-fails-early-fda-approval-alzheimers-donanemab.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Robert Langreth and Nacha Cattan/Bloomberg"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt0dfe71c7f5f5d527/698a39a2457a521371d673ae/eli-lilly-fails-early-fda-approval-alzheimers-donanemab.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Lilly’s Donanemab Fails to Get Early FDA Approval for Alzheimer’s","caption":"eli-lilly-fails-early-fda-approval-alzheimers-donanemab","creditText":"Cristina Arias—Cover/Getty Images","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/drugs/","name":"Drugs"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6248904/eli-lilly-fails-early-fda-approval-alzheimers-donanemab/","name":"Eli Lilly's Alzheimer’s Drug Donanemab Fails to Get Early FDA Approval"}}]}] ```