THE Therapeutic Goods Administration (TGA) has approved the registration of Leqembi (lecanemab) for use as an amyloid-lowering therapy in adult patients for the treatment of mild cognitive impairment due to Alzheimer's disease and early Alzheimer's disease that are apolipoprotein E 4 (APOE4) non-carriers or heterozygotes.
The move reverses the TGA's earlier decisions against registering the drug over concerns about efficacy versus safety risks (PD 04 Mar), and has been welcomed by dementia advocates.
"Access to emerging treatments introduces a new therapeutic era for Alzheimer's disease, the most common cause of dementia in our society," said Professor Christopher Rowe, neurologist and Director of the Australian Dementia Network.
"The registration gives clinicians and patients wider choice of treatment and will bring with it the benefits of competition.
"While this form of treatment is restricted to people in the earliest stages of Alzheimer's disease who are otherwise fit and well, it is an exciting step on the road to effective treatments for dementia," he concluded.
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