TGA decides to not register Leqembi

Australia’s Therapeutic Goods Administration (TGA) yesterday revealed is has made the decision not to register Leqembi (lecanemab) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer's disease and mild Alzheimer's dementia (early Alzheimer’s disease).

The sponsor of lecanemab, the Australian unit of Japanese drugmaker Eisai (TY: 4523), has been notified of the TGA's decision. Eisai Australia has advised the TGA that it intends to request a reconsideration of this decision under Section 60 of the Therapeutic Goods Act 1989.

Main reasons for the decision