Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab under review by the European Medicines Agency Eisai + Biogen.
Eisai Co., Ltd. announced that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: Leqembi), which is currently under review by the European Medicines Agency (EMA)
The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024. The SAG is 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 by the CHMP, or on other scientific issues relevant to the work of the CHMP. Eisai expects the European Commission's decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.
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