The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks the second global approval for the biologic after its clearance in the US earlier this year, with BioArctic receiving a milestone payment of EUR 17 million.
Post-Marketing Commitments and Clinical Data
The authorization from Japan’s MHLW is subject to a post-marketing survey, which will further evaluate the drug’s long-term effects and safety in real-world settings. The decision to approve Leqembi is supported by the results of a Phase III study, which demonstrated that Leqembi slowed down dementia decline by 27% and improved functional independence by 37% compared to a placebo. These findings underscore the potential of Leqembi in managing the progression of Alzheimer’s disease.
Safety Considerations and Adverse Events
While the clinical trial results are promising, the approval also notes common adverse events associated with Leqembi, including cerebral hemorrhage, edema, and falls. These safety concerns will be closely monitored in the post-marketing phase to ensure the drug’s overall benefit-risk profile is favorable for patients.-Fineline Info & Tech
