EU Regulatory Panel Rejects Eisai and Biogen’s Leqembi for Alzheimer’s Treatment

- The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a negative opinion on Biogen and Eisai's Leqembi for Alzheimer's treatment.
- The regulatory panel expressed concerns that the benefits of Leqembi in slowing cognitive deterioration do not sufficiently counterbalance the potential for significant adverse effects linked to the medication.
- Leqembi was granted traditional approval by the U.S. Food and Drug Administration (FDA) in July 2023.
- The European Commission typically adheres to the recommendations provided by the drug regulatory agency, making approval unlikely.
- The rejection presents another obstacle for the companies as they seek to enhance the adoption of the therapy in the United States.