Overview

• The European Commission granted marketing authorization for Eli Lilly’s Donanemab (Kisunla) for early Alzheimer’s, following an EMA recommendation.
• Use is limited to patients in early disease stages with zero or one ApoE4 allele, with confirmed biomarker diagnosis and ApoE4 genotyping required.
• Therapy carries risks of ARIA, including brain swelling and microbleeds, requiring regular MRI surveillance; Donanemab is infused every four weeks, while Lecanemab is given every two weeks.
• Experts estimate only about 1% of people with Alzheimer’s meet all criteria; drug costs are projected around €24,000 per patient yearly plus roughly €10,000 for diagnostics and monitoring, with insurer negotiations ongoing.
• Lecanemab (Leqembi) has been available in Germany since September 1, and Donanemab is expected to reach clinics in the coming months as treatment sites and protocols are established.