TGA approved Donanemab to Alzheimer’s disease. How does this drug work and who will be able to access it?

This week, Australia Administration of therapeutic goods (TGA) approved the drug called Donanamab for people in the early stages of Alzheimer’s disease.

DonanaMab was previously approved in many other countries, including United States.

So what is Donanemab and who will be able to access it in Australia?

How does Donanemab work?

There are over 100 different causes dementiaBut Alzheimer’s disease itself accounts for about 70% of them, what to do The most common form dementia.

It is believed that the disease is caused by the accumulation of two abnormal proteins, amyloid and tau in the brain. It is believed that the first is particularly vital, and the “amyloid hypothesis” – which suggests that amyloid is the key cause of Alzheimer’s disease – he has been conducting research for many years.

Donanemab is a “monoclonal antibody” treatment. Antibodies are proteins that produce an immune system that is associated with harmful foreign “invaders” in the body or goals. Monoclonal antibodies have one specific purpose. In the case of Donanemab, this is amyloid protein. Donanemab is associated with amyloid protein (platelet) protein in the brain and allows our bodies to remove them.

Donanemab is given every month by intravenous infusion.

What do evidence say?

Australia’s approval appears as a result Clinical examination with the participation of 1736 people published in 2023.

This study showed that Donanemab led to a significant slowdown in the progression of the disease in a group of patients who had early Alzheimer’s disease, or delicate cognitive disorders with signs of Alzheimer’s pathology. Before starting the study, all patients were detected by amyloid protein SCANNING OF DOMOTION ANIMALS.

Participants were randomized, and half received Donanamab, and the other half received placebo within 18 months.

For those who received an lively drug, Alzheimer’s disease progressed 35% more slowly compared to those who received placebo. Scientists have determined this with the assist Integrated scale of Alzheimer’s disease assessmentwhich measures cognition and function.

Those who received Donanemab also showed a gigantic reduction in the levels of amyloid in the brain (measured by PET scans). Most, at the end of the study, were considered below the threshold that would normally indicate the presence of Alzheimer’s disease.

These results certainly seem to confirm the hypothesis of amyloids that was caused the question by the results of many Unsuccessful previous tests. They constitute significant progress in our understanding of the disease.

To say that, patients in the study no to correct In terms of cognition or function. They were still falling, although at a much slower pace than those who were not treated.

The real clinical significance was Debate topic. Some experts wondered if the meaning of this result for the patient is worth a potential risk.

Is the drug protected?

About 24% of participants of the rehearsal of the drug experienced brain edema. The rates increased to 40.6% in those with two copies of the gene called APoe4.

Although three -quarters of people who developed brain swelling did not experience any symptoms, three deaths took place in the treated group in a study related to Donanemab, probably as a result of brain edema.

This risk require regular monitoring with MRI scans when administering the drug.

About 26.8% of people who received Donanemab also experienced diminutive brain bleeding (microemorrhages) compared to 12.5% ​​of placebo people.

The cost is a barrier

Reports indicate that Donanemab may cost anywhere USD 40,000 and USD 80,000 Every year in Australia. This puts him beyond the reach of many who can exploit it.

Eli Lilly, producer Donanemab, submitted a request to list the drug in the pharmaceutical benefit program several months. Although this would make the medicine much more accessible to patients, it would be a high cost for taxpayers.

The cost of the drug is an addition to the costs associated with the monitoring required to ensure its safety and effectiveness (such as doctor’s visits, MRI and PET scans).

Who will be able to access it?

This drug is beneficial for people with an early Alzheimer disease, so not everyone with Alzheimer’s disease will gain access to it.

Almost 80% of people who were shown to participate in the trial They were considered inappropriate to continue.

Conditions TGA approval Specify potential patients, they will first have to have a specific level of amyloid protein in their brains. This would be determined by PET scanning or sampling of lumbar spinal fluid puncture.

In addition, patients with two copies of the APoe4 gene were considered inappropriate to receive the drug. TGA assessed the risk/benefit profile so that this group is unfavorable. This genetic profile is only 2% of the general population, but 15% of people with Alzheimer’s disease.

Improving diagnosis and temperament expectations

It is estimated more than 400,000 Australians They have dementia. But only 13% He currently receives a diagnosis within a year of developing symptoms.

Considering people with very early diseases, in order to benefit from this treatment the most, we must significantly expand our diagnostic dementia services.

Finally, you should alleviate your expectations as to what this drug can be achieved reasonably. It is vital to remember that this is not a medicine.