Staff Writer Anika Mangal dives into the controversy surrounding Kisunla – an alleged Alzheimer’s miracle drug.
This article was originally published in print on 14 March 2025.
Alzheimer’s disease is a debilitating type of dementia that affects neurons, which are cells in the brain that aid us in the sensation and perception of the world around us. In Alzheimer’s, these neurons begin to lose their structure and function, leading to issues with cognitive processes such as memory and learning, communication problems, and personality changes.
What actually causes Alzheimer’s?
There are multiple theories but the main one concerns a protein called amyloid: a harmful version of amyloid is produced in patients’ brains, which clumps together to form structures called beta amyloid plaques. These plaques then disrupt the connections between neurons and eventually trigger neuronal death.
Alzheimer’s is a common disease that affected around 480,000 people in the UK in 2024, making it vital to develop viable treatments to provide a better quality of life. There is currently no cure for the disease; however, there are promising new drugs being developed that may at least be able to slow down its progression.
A Miracle Drug?
In July 2024, the USA Food and Drug Administration (FDA) approved a new Alzheimer’s drug called Kisunla. The drug has shown significant improvements in patients with mild cognitive impairment and dementia, supposedly working by clearing up those harmful amyloid plaques in the brains of Alzheimer’s patients.
The FDA based their approval on a study in which patients received the treatment for up to 72 weeks. However, the study also reported numerous side effects associated with taking the drug such as a temporary swelling and/or bleeding of the brain. These side effects were often asymptomatic and temporary, but in some patients, they were quite severe and even fatal.
FDA Approval Shrouded with Controversy
While the drug appears to be quite effective in treating Alzheimer’s, there is significant controversy surrounding the FDA’s approval – 8 out of 11 members of Kisunla’s advisory committee reportedly had ties with Kisunla’s manufacturing company Eli Lilly, or were conducting research on drugs similar to Kisunla.
These potential conflicts of interest suggest that the decision to approve Kisunla may have been influenced, begging the question: did these experts properly weigh the potential side effects against its potential efficacy, and is Kisunla actually safe for commercial use?
UK Approval of Kisunla
As of October 2024, the controversial drug was also approved for use in the UK. However, it will not be funded by the government. The UK’s National Institute for Care and Excellence (NICE) stated that the high cost of the drug and its potentially severe side effects means “it cannot currently be considered good value for the taxpayer”. Another reason was a lack of evidence for its efficacy as very few human studies into Kisunla have been conducted.
What Does This Mean?
The field of Alzheimer’s research is constantly growing and evolving, bringing about new and potentially groundbreaking treatments. However, the approval of these treatments is, unfortunately, impacted by external motives which we must acknowledge. In the case of Kisunla, the controversy surrounding its approval raises a concerning question: do health advisory boards really act in the interest of the patient?
About the author
