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The Guardian - AU
The Guardian - AU
Politics
Melissa Davey Medical editor

Alzheimer’s ‘breakthrough’ stalls: why a much-hyped drug is facing approval delays

FDA Dementia Disease Brain Al Jazeera Eli Lilly Food and Drug Administration
Clinical research to develop a possible cure for Alzheimers and dementia in the lab
The Food and Drug Administration has delayed approval of Alzheimer’s drug donanemab and wants a panel to scrutinise safety and efficacy data. Photograph: Tek Image/Science Photo Library/Getty Images

It was heralded in news articles as a “breakthrough”, a “turning point” and a “gamechanger” for Alzheimer’s disease. Some experts went so far as to call the drug, donanemab, the “beginning of the end” for the debilitating condition.

Pharmaceutical company Eli Lilly in May 2023 released data from a clinical trial they said showed donanemab slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease by 35% over 18 months.

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