Posted by Michael Wonder on 17 Oct 2024
TGA's decision to not register lecanemab (Leqembi)
16 October 2024 - The TGA has made the decision not to register lecanemab (Leqembi) for the treatment of patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia (early Alzheimer’s disease).
The sponsor of lecanemab Eisai, has been notified of the TGA's decision. Eisai has advised the TGA that it intends to request a reconsideration of this decision under Section 60 of the Therapeutic Goods Act 1989.
