Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation application (MAA) for Leqembi® (lecanemab) which is under review by the European Medicines Agency (EMA). The SAG is expected to meet before 31 March 2024. The SAG is being convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation.
On 9 January 2024, the Chinese NMPA approved Leqembi® as a treatment for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.