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19 June, 2021

Alzheimer drug under review by TGA

Dementia Australia has welcomed the announcement by the United States Food and Drug Administration (FDA) approving the first disease modifying treatment for Alzheimer’s disease and MCI (Mild Cognitive Impairment) related to Alzheimer’s disease for almost 20 years.

New Alzheimer's drug is under review by the TGA

Dementia Australia CEO Maree McCabe said this was exciting news for the entire dementia community globally. 

“This announcement provides real hope for people who are developing symptoms and in the early stages of Alzheimer’s disease,” Ms McCabe said.

“Importantly this will result in further research investment into more treatments for all forms of dementia.”

The drug will be available in the United States and is currently under review by the Therapeutic Goods Administration (TGA) in Australia with an announcement expected early in 2022.

“It may be some time before it is accessible in Australia,” Ms McCabe said.

“If or when that time comes it will be important for people to have access to appropriate information to enable them to make an informed choice about their treatment.”

Aducanumab includes antibodies designed to attach to and remove amyloid plaques. These plaques are thought to cause the damage in the brain that leads to Alzheimer’s disease.

Dementia Australia Honorary Medical Advisor Associate Professor Michael Woodward AM said sadly we do not yet have a cure for Alzheimer's disease, but through removing the toxic amyloid protein with this drug we can significantly reduce the rate of memory and other decline. 

“We can’t bring back brain tissue that has been damaged irreversibly but we can protect brain tissue by removing the toxic effects of this amyloid,” Assoc Prof Woodward said.

“The original trials were terminated when it looked like the drug wasn’t working – at that stage there weren’t many people on the highest dose of the drug. 

“When researchers examined more data that included more people who had been, for longer periods, on the highest dose they demonstrated a significant effect.

“Aducanumab should only be used in the early stages of dementia and may not work for everyone.

“It can also cause side effects and these need to be carefully monitored with regular MRIs. 

“It is possible that, if used very early in Alzheimer's disease, this drug will prevent the emergence of the symptoms of Alzheimer's, but there is still research to be done in this area.” 

Ms McCabe acknowledged the 100 Australians who have been part of the study. 

“I applaud them and all trial participants for their contribution to this research,” Ms McCabe said.

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