On 16 October 2024, Australia’s Therapeutic Goods Administration (TGA) reported its decision not to register Leqembi® (lecanemab) 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 is based on the TGA’s opinion that demonstrated efficacy did not outweigh the safety risks associated with use of lecanemab. Dementia Australia has issued a media statement calling the decision a ‘blow’ for Australians living with Alzheimer’s disease.
Eisai Australia has advised the TGA that it intends to request reconsideration of the decision.
Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the UK, US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the European Union, Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.
In a draft guidance issued on 22 August 2024, the UK’s National Institute for Health and Care Excellence (NICE) found that the benefits of lecanemab were too small to warrant making the drug available on the NHS.