TGA approves registration of lecanemab (LEQEMBI)

On 23 September 2025 the TGA made the decision to approve the registration of the lecanemab (LEQEMBI).

What is LEQEMBI approved for

The approval is for the following indication:

LEQEMBI is indicated in adult patients with a diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) that are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes.

Beta amyloid evidence consistent with Alzheimer’s disease (AD) should be confirmed using a validated test prior to initiating treatment.

Decision history

In October 2024, the TGA made an initial decision not to approve lecanemab (LEQEMBI). The sponsor of the medicine, Eisai Australia Pty Ltd (Eisai Aust) requested a review of this decision, however the delegate upheld the initial decision to not approve the medicine in February 2025.

The TGA found that whilst safety and efficacy had been satisfactorily established for some patients (namely, people who do not carry copies of the APOE4 gene), safety had not been satisfactorily established for patients who carry one copy of the APOE4 gene (APOE4 heterozygous carriers). The TGA also found that both safety and efficacy had not been established for patients who carry two copies of the APOE4 gene.

Administrative Review Tribunal

On 26 March 2025, Eisai Aust applied to the Administrative Review Tribunal (ART) for review of the TGA’s decision to not approve LEQEMBI. During the course of the ART dispute resolution process, the TGA received several additional submissions from Eisai Aust, which focused on safety in APOE4 heterozygous carriers. These submissions included new risk management proposals and updated Product Information. The submissions were designed to address the outstanding safety concerns raised by the TGA, for example the submission included an 18 month review for cognitive function testing and clinical symptom assessment to determine if the patient had progressed to moderate Alzheimer's dementia.

After thorough review and detailed discussions with Eisai Aust, the TGA determined that the additional submissions satisfactorily addressed the outstanding concerns regarding the safety of the Medicine. By consent of both of the parties, the ART made a decision to remit the matter back to the TGA for reconsideration on 11 September 2025.

The TGA made the decision to approve the medicine on 23 September 2025. Details relating to the approved use of the medicine, including the approved indication are available in the Product Information.

More information

The TGA has published a detailed summary of the initial decision, along with the outcome of this review, via an Australian Public Assessment Report.

Questions relating to supply of LEQEMBI should be directed to the sponsor of the medicine, Eisai Australia Pty Ltd.

The TGA encourages affected patients to speak to their doctor if they have questions or concerns about this medicine.