June 2026 June 2026:Eli Lilly and Company announced that the EMA's CHMP recommended marketing authorization for Daybu® (trofinetide) following re-examination for the treatment of Rett syndrome in adults and pediatric patients aged five years and older, expanding the pipeline of therapies for rare neurodevelopmental and neurodegenerative disorders in Europe.
April 2026 Sanofi received a positive CHMP opinion from the EMA for tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS), representing a major advancement in therapies targeting neurodegenerative neurological disorders in Europe.
October 2025 October 2025:European Commission granted marketing authorization for Kisunla® (donanemab) for eligible adults with early Alzheimer's disease, expanding the availability of disease-modifying treatment options across the European Union.
July 2025 July 2025:Eli Lilly and Company received a positive recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for Kisunla® (donanemab) for the treatment of adults with early symptomatic Alzheimer's disease. The recommendation marked a significant regulatory milestone for disease-modifying Alzheimer's therapies in Europe.