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Eli Lilly’s Alzheimer’s drug Kisunla has failed to get support from the European Medicines Agency over serious side effects and three patient deaths.
The agency’s human medicines committee (CHMP) recommended that the European Commission reject Lilly’s donanemab, branded as Kisunla, saying its benefits don’t outweigh the risks of potential swelling and bleeding in the brain, called amyloid‑related imaging abnormalities (ARIA).
The opinion marks another blow for anti-amyloid treatments in Europe. CHMP only recently gave the go-ahead for Eisai and Biogen’s Leqembi in November, after previously rejecting the drug over safety issues in July 2024. The regulator rejected Biogen’s Aduhelm in 2021, leading the company to withdraw its application a year later.
The EC has the final say over new drug approvals, but it normally follows CHMP’s recommendations.
CHMP has been wary of recommending Alzheimer’s drugs that risk the development of ARIAs. Kisunla has higher rates of ARIA compared to Leqembi. Both Aduhelm and Leqembi are FDA-approved, and Lilly won approval for Kisunla in the US last July.
William Blair analysts view the Kisunla rejection as “unsurprising” given Leqembi’s initial rejection. But unlike CHMP’s decision to then give a positive opinion for Leqembi, there is a “real risk” that Kisunla may not make European approval given its higher rate of ARIAs. This can only be a win for Biogen and Eisai, the analysts said.
ARIAs were recorded in 36.8% of people who took Kisunla compared with 14.9% who received the placebo, which resulted in three patient deaths, CHMP said in its latest opinion.
Lilly said Friday it was “disappointed” by the CHMP’s decision and will look for a “re-examination” from the agency. The company has 15 days to submit for another review process. Kisunla is estimated to pull in around $2 billion in global sales in 2030, according to GlobalData analysts.
Lilly’s application to CHMP used data from 1,736 patients enrolled in a Phase 3 study called TRAILBLAZER-ALZ 2, which was used to secure approvals in other markets including the UK, Japan, and China.
Kisunla is given to a patient through an infusion drip once every four weeks and contains a monoclonal antibody that attaches to plaques that are formed in the brain in patients with Alzheimer’s disease.
原文链接：endpts.com
原文注释：
Eli Lilly’s Alzheimer’s drug Kisunla 美国制药公司礼来（Eli Lilly）的阿尔茨海默病药物donanemab（商品名为Kisunla）是一款通过静脉注射的单克隆抗体药物，旨在清除大脑中导致阿尔茨海默病的淀粉样蛋白斑块，从而缓解早期阿尔茨海默症患者的认知能力丧失。2024年7月2日，美国食品药品监督管理局（FDA）正式批准美国礼来公司的新药Kisunla上市。
Eisai and Biogen’s Leqembi 由卫材（Eisai）与渤健（Biogen）联合开发的Leqembi，是一种抗体药物，主要用于治疗阿尔茨海默病。2024年8月23日，卫材和渤健宣布，其联合开发的阿尔茨海默病疗法Leqembi（lecanemab）已获得英国药品和健康产品管理局（MHRA）的上市许可。该疗法适用于治疗携带或不携带APOE E4等位基因的阿尔茨海默病（AD）引起的轻度认知障碍（MCI）和轻度痴呆成人患者。
Biogen’s Aduhelm Aduhelm是一种靶向β淀粉样蛋白的单克隆抗体药物，主要用于治疗阿尔茨海默病。Aduhelm是自2003年以来获批用于阿尔茨海默病的首个新型疗法，是首个针对阿尔茨海默病潜在病理生理学的治疗药物，即大脑中存在β淀粉样蛋白斑块。
词汇：swelling n.肿块；amyloid n.淀粉样蛋白；blow n.打击；EC abbr.欧洲药品管理局；wary adj.谨慎的；placebo n.安慰剂；infusion n.输液
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