Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia has refused to approve its lecanemab for the treatment of early Alzheimer’s disease (AD), specifically for mild cognitive impairment due to AD and mild AD dementia.
Background and Partnerships
Eisai entered into a licensing agreement with BioArctic AB (OTCMKTS: BRCTF) in 2007, securing global rights to lecanemab. The company later established a joint development and commercialization agreement for the drug with Biogen Inc. (NASDAQ: BIIB). Lecanemab selectively targets soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are key components of Aβ plaques in AD, thereby reducing both Aβ protofibrils and plaques in the brain. The drug is currently registered in the US, Japan, China, South Korea, and other regions for AD patients.
TGA Decision and Eisai’s Response
In October 2024, the TGA decided not to register lecanemab in Australia for early AD treatment. In December 2024, Eisai requested reconsideration, proposing the same apolipoprotein E4 (ApoE4) non-carrier and heterozygote indication agreed upon by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). During the reconsideration, the TGA proposed a narrower therapeutic indication only for ApoE4 non-carriers, citing concerns that an increasing number of ApoE4 alleles is a potential risk factor for ARIA (Amyloid-Related Imaging Abnormalities). The TGA did not accept that safety has been established for ApoE4 heterozygotes. Eisai proposed alternative indications, including maintaining the ApoE4 non-carrier and heterozygote indication with heterozygotes treated in specialist centers under expert supervision, but the TGA rejected these proposals.
Future Steps
Eisai remains committed to ensuring eligible Australians with early Alzheimer’s disease can access lecanemab and is exploring options, including potentially seeking review by the Administrative Review Tribunal.-Fineline Info & Tech
Leave a Reply