The Ministry of Food and Drug Safety (MFDS) stated that there was no procedural issue during the approval of 'Leqembi (lecanemab),' a dementia treatment, that omitted the review by the Central Pharmaceutical Affairs Advisory Committee (hereafter referred to as the "Advisory Committee").

Out of 33 active ingredients of new drugs that received domestic approval since 2023, only 6 active ingredients were reviewed by the Advisory Committee. The final approval of Leqembi was based on its effects, treatment options, and monitoring plans.

In answering the questions from media reporters on October 22nd, the MFDS stated that regarding the procedural issue of Leqembi approval, "The specialists in