European committee rejects Eli Lilly's Alzheimer’s drug over safety concerns

In March 2025, a European regulatory committee announced its decision to reject Eli Lilly’s Alzheimer’s treatment, Kisunla, which was previously approved in the United States. The rejection stems from significant concerns regarding the drug's safety, particularly the potential risks of brain bleeding and swelling among patients who would use it. The European Medicines Agency's Committee for Medicinal Products for Human Use determined that the benefits offered by Kisunla did not sufficiently outweigh these serious risks, leading to a recommendation against granting marketing authorization in the European market. Eli Lilly had high hopes for Kisunla as it represents a breakthrough treatment option, similar to another drug, Leqembi, which was approved a year prior. Both drugs are designed to target the accumulation of amyloid plaques in the brain, a key factor in the progression of Alzheimer’s disease. The U.S. government had approved Kisunla in July 2024 for early-stage dementia cases linked to the disease, and it has already been authorized for use in markets such as Japan and China. Despite this, the European agency’s conclusions have halted the drug’s potential rollout within Europe. Moreover, the same committee had previously expressed reservations about Leqembi due to similar safety issues. However, it did reverse its earlier decision a few months later, illustrating a complex landscape for Alzheimer’s treatment approvals in Europe. The committee's latest decision on Kisunla has sparked discussions regarding the future of Alzheimer's treatments and how safety profiles impact regulatory decisions. As Eli Lilly considers appealing this decision through a re-examination process, the pharmaceutical company aims to engage further with European officials to reassess the drug's potential. Questions remain about patient eligibility for these therapies and the actual duration of cognitive benefits that diseases like Alzheimer’s can offer with such treatments. The development of Kisunla and its comparison with other emerging therapies underscore the challenging balance between innovative treatment options and the necessity of patient safety concerns in the approval process, as seen by regulatory bodies worldwide.