TGA's decision to not register lecanemab (LEQEMBI)

The Therapeutic Goods Administration (TGA) has made the decision not to register lecanemab (LEQEMBI) 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 (LEQEMBI), Eisai Australia Pty Ltd, 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.

What were the main reasons for the decision to refuse registration?

The TGA delegate decided not to register LEQEMBI on the basis that the demonstrated efficacy did not outweigh the safety risks associated with the use of this medicine.

In particular, clinical study data demonstrated that patients treated with LEQEMBI experienced a reduction in disease progression compared to those given a placebo, however this difference was not deemed significant enough to provide a meaningful clinical benefit or to outweigh the associated safety risks. In particular, the TGA delegate considered the frequent occurrence of amyloid-related imaging abnormalities (ARIA) in patients treated with LEQEMBI.

This decision was supported by independent expert advice from the TGA's Advisory Committee on Medicines (ACM).

Further information

The TGA will publish a detailed summary of this decision, along with the outcome of any review, via an Australian Public Assessment Report, when any review period is complete.

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