Donanemab update: new Alzheimer’s disease treatment approved by the FDA

On 2 July 2024, the U.S. Food and Drug Administration (FDA) approved the marketing authorisation for Kisunla (donanemab) for adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or the mild dementia stage of Alzheimer’s disease. 

Donanemab is the second traditional approval of an Alzheimer’s treatment by the FDA, after, Leqembi (lecanemab) in July 2023, marking another milestone in the dementia treatment landscape. Previously, Aduhelm (aducanumab), received accelerated approval in June 2021. 

In response to the news, ADI CEO Paola Barbarino said: 

“Today’s announcement is welcome news to our community,  and those living with dementia and their loved ones across the world. While there is some way to go before it will be accessible to all those eligible to receive the treatment, it is our hope that this news will bring further research and investment in this sector, as well as increased and improved health care infrastructure to support its usage. 

While this is a significant milestone, it will take some time before treatments like donanemab become universally accessible, even in high-income countries. Evidence suggests that health and care systems are not adequately prepared to support the prescription of these medications. Countries may also seek to conduct more Health Technology Assessments (HTA) to further determine the efficiency, safety, and cost-effectiveness of these treatments. 

ADI will continue to provide further information on this news as and when it becomes available. 

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