Alzheimer’s Drug Leqembi Receives FDA Approval, But Its Impact May Be Limited
The US Food and Drug Administration (FDA) has recently granted approval to the drug Leqembi for the treatment of Alzheimer’s disease. While this approval is seen as a positive step forward, some researchers have expressed concerns about its limited impact. Clinical trials have shown that Leqembi can slow the progression of the disease in 27% of patients in the early stages of Alzheimer’s. However, it is important to note that the drug does not improve patients’ conditions or halt the disease’s progression.
Leqembi, also known as Lecanemab, is the second major drug to receive approval for the treatment of Alzheimer’s, following Aduhelm’s FDA approval over two years ago. Aduhelm’s approval was controversial, with some scientists questioning the effectiveness of the drug based on clinical trial data. European regulators did not approve Aduhelm for use.
Researchers believe that Leqembi offers a clearer indication of its ability to remove beta-amyloid plaques, fatty deposits that accumulate in the brains of Alzheimer’s patients. Professor Paul Matthews, from Imperial College London, explains that Leqembi provides more confidence in slowing the brain’s changes associated with the disease compared to Aduhelm.
Both Leqembi and Aduhelm contain antibodies that bind to beta-amyloid material. However, they differ in their attachment methods, which may explain the disparity in their ability to remove beta-amyloid or interfere with its impact on the brain. While Leqembi’s FDA approval is considered standard, it is essential to acknowledge the increased risks associated with the drug, including brain swelling and bleeding, which can be fatal in extreme cases.
Not all dementia researchers are convinced that Leqembi represents a significant advancement in treatment. Professor Rob Howard from University College London argues that the drug’s impact is limited, with treatment differences being relatively small and possibly not clinically noticeable. Furthermore, he believes the drug may not offer enough benefits for its cost, particularly as it is reported to be $26,500 per patient annually in the US.
Moreover, Dr. Ivan Koychev, a senior clinical researcher at the University of Oxford, suggests that implementing Leqembi into memory clinics would require a complete overhaul. This would involve the intravenous administration of the drug, genetic testing to identify individuals at risk of side effects, and regular MRI scans for monitoring these side effects. While the results may not be impressive for individual patients, Dr. Koychev emphasizes that the drug’s approval could lead to increased investment and improved treatments.
Alzheimer’s disease is responsible for about two-thirds of dementia cases and is characterized by a loss of neuronal connections in the brain. Symptoms, such as memory loss, altered behavior, and speech problems, typically emerge after years of undetected brain changes.
To maximize the potential benefits of Leqembi, it may be necessary to administer the drug earlier to individuals before symptoms develop. However, this approach requires early identification of those likely to develop Alzheimer’s symptoms. Efforts to improve early recognition are ongoing, and Prof. Matthews suggests that additional blood tests during routine check-ups could potentially identify individuals who may benefit from preemptive treatment.
In conclusion, the approval of the Alzheimer’s drug Leqembi by the FDA is seen as a positive development. However, there are concerns about its limited impact and potential risks associated with the drug. While Leqembi has shown promise in slowing the progression of the disease, it does not bring about improvements or stop its advancement. Further research and evaluation are necessary to fully understand the effectiveness and long-term benefits of this drug in the treatment of Alzheimer’s disease.
