THE Therapeutic Goods Administration (TGA) has registered Kisunla (donanemab, Eli Lilly) for the treatment of adults with early symptomatic Alzheimer's disease who have a specific genetic profile and the confirmed presence of amyloid plaque in the brain.
The drug works to remove the build-up of amyloid plaques (pictured above), a protein in the brain that can lead to memory loss and impaired cognition, and is the first treatment registered in Australia that works to address the underlying cause of the neurodegenerative disease.
"The registration of donanemab is very exciting - as clinicians, we've been waiting a very long time to be able to offer patients a treatment of this nature," said Professor Michael Woodward, Head of Dementia Research and Senior Clinician, Memory Clinic at Austin Health in Melbourne.
"Donanemab is for people in the early stages of Alzheimer's disease with a defined genetic profile, where symptoms like memory lapses and mood changes are present alongside the build-up of amyloid plaques in the brain," Prof Woodward continued.
"There is an important window of opportunity when it is possible to detect, diagnose and treat Alzheimer's disease with the goal that patients can maintain their independence for longer."
It is estimated that 600,000 Australians are currently living with Alzheimer's, which is the nation's third leading cause of death.
Approximately 450,000 are in the early stages of the disease and may be eligible for treatment with the drug.
"The availability of donanemab is a major development at a time when more and more Australians and their families are being impacted by this insidious disease," Prof Woodward said.
Eli Lilly has lodged an application with the Pharmaceutical Benefits Advisory Committee (PBAC) to get the drug listed on the PBS.
In the meantime, doctors will be able to prescribe the medicine on private prescription.
Eli Lilly is also working closely with specialist centres to build confidence and capabilities to translate clinical trial experience with Kisunla into medical practice. KB
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