FDA approves drug for early symptomatic Alzheimer’s disease

The U.S. Food and Drug Administration (FDA) has approved the Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease after months of delays.

Clinical trials of the new drug were performed on 1736 patients with mild cognitive impairment or mild dementia and results showed a slowing of cognitive and functional decline by up to 35 per cent.

Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said that the clinical trials showed patients treated with Kisunla demonstrated a significant reduction in clinical decline.

“The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease," Dr Buracchio said.

"Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.” 

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

In Australia, donanemab is currently under review by the Therapeutic Goods Administration.

Tori Brown, general manager of Eli Lilly (Lilly) Australia said early diagnosis is key to the success of drugs like this.

“This US regulatory approval is an urgent reminder that Australia must prepare for this new era in medicine with the upcoming arrival of Alzheimer’s disease-modifying therapies," Ms. Brown said.

“Disease-modifying therapies won’t be appropriate for everyone living with Alzheimer’s disease, but for the first time in decades, they present an option, once diagnosed, in the management of the condition in its early stage.

“Time is critical for individuals living with Alzheimer’s disease, yet it still takes years to receive an accurate diagnosis in Australia – often once cognitive function has already declined.

“As a nation we must prioritise earlier brain health checks and ensure doctors have clear pathways to detect, diagnose and support their patients – long before cognition declines."

Data from the Australian Institute of Health and Welfare showed that, as at 2022, the leading cause of death for Australian women was dementia including Alzheimer’s, accounting for 12 per cent of all deaths. For males, dementia including Alzheimer's disease was second only to coronary disease.

Professor Tanya Buchanan, CEO of Dementia Australia, reiterated that medications like donanemab must be supported by an efficient and accessible healthcare system.

"Dementia Australia welcomes the Federal Drug Administration approval of donanemab for use in the
United States, which provides further hope for people in the early stages of Alzheimer’s disease," Ms Buchanan said.

"While this is a significant development, it needs to be understood that donanemab is not a cure and it is only suitable for people in the early stages of cognitive decline.

"As this and other treatments become available, if approved in Australia, we must ensure that our health
systems are ready and make sure that access to treatment is equitable and available to everyone.

"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."