FDA approves early Alzheimer’s drug

2 minute read

Lecanemab is the second drug approved in the US, but there’s still nothing in Australia.

Australian experts have welcomed the FDA’s accelerated approval of lecanemab, a drug that slows the progression of Alzheimer’s for people in the early stage of the disease by removing toxic amyloid protein from the brain.

A study published in the NEJM this month found a 27% decline in disease progression over 18 months.

“What this means is that if you took the drug for two years you would be up to nine months better off and that is a significant benefit,” said Dementia Australia Honorary Medical Advisory Associate Professor Michael Woodward.

He said the drug was “an important step and a move in the right direction for treating Alzheimer’s disease for which we still do not have a cure”, but he also noted that there were side-effects of the drug that needed careful monitoring through regular MRIs.

The study found that serious adverse events occurred in 14% of patients in the lecanemab group compared with around 11% of the placebo group.

The most common of these were infusion-related reactions, amyloid related imaging abnormalities (ARIA), atrial fibrillation, syncope and angina pectoris.

This is the second such drug approved by the FDA. The first was aducanumab in June 2021. That proved controversial because while it did clear amyloid plaque, there was disagreement about whether the results showed an improvement in dementia symptoms. The drug has not been approved for use in Australia in Europe.

Dementia Australia CEO Maree McCabe described the FDA decision as exciting news for the entire dementia community globally.

“With dementia the second leading cause of death of Australians, and the leading cause of death of Australian women, I welcome any steps taken towards improving the lives of people living with dementia, their families and carers,” she said.

“I do however acknowledge that lecanemab has only been approved by the FDA for use within the United States and comes with possible side effects that need to be carefully monitored by health professionals.”

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