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The drug, which is sold as LEQEMBI, has been given the green light by the TGA after an initial rejection last year.
There are now more options for the treatment of mild Alzheimer’s disease in Australia.
A further treatment for mild Alzheimer’s disease has been given regulatory approval, the Therapeutic Goods Administration (TGA) announced this week.
Lecanemab, which is sold as LEQEMBI, is now indicated in adult patients with a diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease.
It joins a rapidly emerging area of medications following the TGA’s registration of Donanemab (sold as Kisunla) in May this year, the first new treatment for early Alzheimer’s in Australia in 25 years.
Dementia Australia CEO Professor Tanya Buchanan welcomed the TGA’s announcement.
‘This, along with the approval of Kisunla by the TGA earlier this year and the many other treatments currently being developed, heralds a new and exciting era for the treatment of dementia,’ Professor Buchanan said.
‘It is important to note that lecanemab does come with possible side effects that need to be carefully communicated to patients so they can make an informed choice, and the treatment needs to be monitored by health professionals.
‘We also need to ensure people understand that lecanemab is not a cure and is only suitable for people in the early stages of Alzheimer’s disease which is why it is so important for people to receive a timely diagnosis.’
Lecanemab was rejected by the TGA last year due to safety concerns. Additional submissions received during the review process from the medication’s sponsor Eisai Aust ‘satisfactorily addressed the outstanding concerns’, according to the TGA.
The medication is an amyloid-lowering therapy in adult patients. The TGA said beta amyloid evidence consistent with Alzheimer’s disease should be confirmed before treatment begins.
Revised figures released by the Australian Institute of Health and Welfare this month indicate that dementia is now the leading cause of death among Australians.
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