Overview

• France’s Haute Autorité de Santé on September 9 declined early access for Leqembi, citing modest efficacy with a worrisome tolerance profile that includes risks of cerebral hemorrhage and edema, meaning no immediate reimbursement.
• The European Medicines Agency issued a positive opinion in 2025 limited to mildly affected patients with genetic risk screening required, highlighting divergent European approaches as advocacy groups press for availability in some countries.
• A first blood-based biomarker test has been authorized in the United States since May, while the United Kingdom has launched a large clinical trial to assess whether such screening improves outcomes; Europe has not adopted routine use.
• New monoclonal antibodies, including Kisunla (donanemab) and Leqembi (lecanemab), target beta-amyloid and show only modest benefit confined to early-stage patients, with experts warning of serious brain-bleed risks.
• Prevention research identifies many modifiable risks, yet trials show limited cognitive gains so far, with a recent JAMA study finding only slight slowing over two years as global prevalence exceeds 35 million, including roughly one million in France.