TGA approves donanemab for treatment of Alzheimer’s in Australia

In positive news for Australians, the Therapeutic Goods Administration (TGA) has approved a drug that has been proven to significantly slow the progression of Alzheimer’s disease.

Donanemab (Kisunla) is the first new drug approved in Australia for the treatment of mild cognitive impairment in 25 years.

The monthly injection works by breaking up and clearing the build up of amyloid plaques (a hallmark of Alzheimer's disease) in the brains of people with mild cognitive impairment.

The U.S. Food and Drug Administration (FDA) approved the injection for the treatment of Alzheimer’s disease almost a year ago, and has approval in the UK, Japan and China as well.

Developed by American pharmaceutical giant Eli Lilly, the FDA’s approval of donanemab was not without controversy. The Administration delayed the drug’s approval twice following Eli Lilly’s application in July 2023. According to a statement released by the company, this was because the FDA wanted to “further understand topics” related to the drug’s safety and effectiveness.

Lilly Australia and New Zealand general manager Tori Brown said the registration of donanemab in Australia is “a pivotal moment that will redefine how Alzheimer’s disease is managed when symptoms first present”.

“The registration of Kisunla in Australia is enormously meaningful for people with early symptomatic Alzheimer's disease who urgently require effective treatment options,” Ms Brown said.

“Lilly has been at the forefront of Alzheimer’s disease research for more than 35 years. It’s incredibly rewarding to know that these tireless efforts have led to this moment in time.”

Early detection vital

Professor Michael Woodward, head of Dementia Research and Senior Clinician at the Austin Health Memory Clinic in Melbourne has been integral to the clinical trial of the drug in Australia.

The drug’s approval has been a pinnacle in his career, he told the Herald Sun.

“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,” Professor Woodward said.

“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.

“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. 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.”

Related: Dementia drug rejected by TGA | TGA doubles down on rejection of Alzheimer’s drug | FDA approves drug for early symptomatic Alzheimer’s disease | “Shiny new treatment:” High cost means new Alzheimer’s drugs not available to all | “As many people as possible”: Researchers recruit for promising dementia drug trial

Welcome news

Dementia currently impacts over 400,000 people nationwide and is the number one cause of death for Australian women.

Australian Dementia Network (ADNeT) director Professor Christopher Rowe said it is absolutely vital that medications like donanemab are supported by an efficient and accessible healthcare system.

“We must now ensure our health system is ready with the diagnostic tools and expert staff to bring these new treatments to patients.”

Dementia Australia chief Professor Tanya Buchanan added that the public should note that the treatment does come with possible side effects and that close monitoring is vital while taking it.

“We also need to ensure people understand that donanemab is not a cure and is only suitable for people in the early stages of Alzheimer’s disease with a defined genetic profile – which is why it is so important for people to receive a timely diagnosis,” she said.

Clinical trials of the medication revealed patients who were administering the drug were at an elevated risk of brain bleeds.

“We need to raise awareness and understanding of dementia so we can ensure people with concerns about their cognition are seeking information and support as early as possible.

“We know the earlier people access support and services the better their health, care and lifestyle outcomes.”

More on dementia

Also last week, researchers released a new study revealing links between the virus responsible for the common cold sore and the development of Alzheimer’s disease.

And scientists believe antiviral treatments may help lower the risk of developing the debilitating brain disorder.

The study, published in the medical journal BMJ Open, looked at the history of people who had the virus behind cold sores known as herpes simplex 1 (HSV-1).

It matched more than 340,000 people with and without Alzheimer’s and assessed their history of herpes virus infections using US health insurance data between 2006 and 2021.

The risk of developing Alzheimer’s increases with age.

Based on the data, those with the disease were also 80 per cent more likely to have had an HSV-1 diagnosis.

The study found various infectious agents had been implicated in the development of Alzheimer’s disease.

The most studied of these is HSV-1, which affected more than two-thirds of under-50s around the globe in 2016 alone.

Exactly how HSV-1 and other neurotropic viruses might increase the risk of dementia wasn’t clear, the researchers said.

“However, studies have shown that inflammatory alterations in the brain caused by HSV infection are pivotal in [Alzheimer’s disease] development,” they said.

Among the 2,330 people with a history of HSV-1 infection, (40 per cent) used antiherpetic medication after their diagnosis, which meant they were 17 per cent less likely to develop Alzheimer’s disease than those who didn’t get treatment.

Professor of Health Economics of Ageing at the University of Queensland Brenda Gannon said that while the study indicates some potential overall, a lot more research would be required to determine if anti-viral therapies will actually reduce the probability of people with cold sores developing Alzheimer’s disease.

“As the authors state, it does not indicate cause and effect, but they do find it a potential avenue to explore further,” Professor Gannon said.

“Further research would be required to ensure the study is more widely representative, since the authors note that not all populations are included in the data, e.g. those over 65 who receive free health care (Medicare).

“The study does not provide detail on who may benefit, for example does it help disadvantaged groups more, and who does it work together with other non-pharmacological treatments for lifestyle improvement?

“From a health economics perspective, it is unlikely that anti-viral therapy would be funded for the Australian population, until further evidence on effectiveness in prevention and then cost-effectiveness overall, including additional use of health care resources, is provided.

“More details on the health and socio-economics status of individuals are also warranted, to help determine who may benefit from the therapy.”