On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease (AD). Eisai is “extremely disappointed and surprised by the TGA’s decision” and is exploring its options, including the possibility of seeking a review of the TGA’s decision by Australia’s Administrative Review Tribunal.
The TGA issued a decision in October 2024 not to approve Leqembi® for the treatment of patients with mild Alzheimer’s dementia (early Alzheimer’s disease) and mild cognitive impairment (MCI) due to Alzheimer’s disease. The decision was based on the TGA’s opinion that demonstrated efficacy of the drug did not outweigh the safety risks associated with use of lecanemab. Eisai subsequently requested reconsideration of the decision.
As part of the reconsideration, the TGA proposed a narrowed therapeutic indication but ultimately no indication could be agreed upon by the TGA and Eisai.
Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. In February 2025, the CHMP reaffirmed its positive recommendation for approval of lecanemab for MCI and mild dementia due to Alzheimer’s disease.