Researchers have reported that a new experimental drug for Alzheimer’s disease, donanemab, can moderately slow the progression of the disease by about four to seven months. Eli Lilly and Co. is currently seeking approval from the Food and Drug Administration for donanemab, which would make it the second Alzheimer’s treatment proven to delay the disease after the recent approval of Leqembi. This news has brought hope to the medical community and patients suffering from Alzheimer’s. Dr. John Sims from Lilly stated that while the disease cannot be cured, meaningful treatments can still greatly improve patients’ lives, as is the case with diabetes. In May, Lilly announced that donanemab showed promise, and now the full results of a study involving 1,700 patients have been published.
Both donanemab and Leqembi are lab-made antibodies that are administered via IV and target sticky amyloid buildup, a key culprit in Alzheimer’s. However, both drugs carry serious safety concerns, such as brain swelling and bleeding, which were linked to three deaths in the Lilly study. While these drugs represent a new era in Alzheimer’s therapy, there are still significant questions regarding which patients should use them and how much benefit they will actually provide. Dr. Eric Widera of the University of California, San Francisco, expressed concerns about the cost, risk, and complexity associated with amyloid antibodies in an accompanying editorial.
The study conducted by Lilly enrolled patients between the ages of 60 and 85 in the early stages of Alzheimer’s. Half received monthly infusions of donanemab while the other half received dummy infusions for 18 months. Patients were switched to dummy infusions if enough amyloid cleared out, and levels of abnormal tau, another culprit in the disease, were also tracked. The results showed that although both groups declined during the study, those given donanemab worsened about 22% more slowly. Patients with low to medium tau levels saw a 35% slower decline, suggesting that the drug may be more effective in earlier stages of the disease. Overall, donanemab delayed the worsening of patients’ conditions by about four to seven months, according to the report.
The main safety concern with donanemab is brain swelling and bleeding, which can be serious or even fatal. Around a quarter of patients experienced evidence of brain swelling, and about 20% had microbleeds. Patients receiving any amyloid-targeted therapy require regular brain scans to check for these side effects, which adds to the cost and time needed for treatment. Widera suggested that temporarily stopping donanemab treatment in patients who respond well could help alleviate these challenges. However, it is still unknown if patients may need to resume treatment in the future, as the amyloid does not come back aggressively. It is important to note that the study predominantly involved white participants, and more research is needed to determine how other populations respond to the drug.
The approval of Leqembi and the promising data for donanemab have renewed interest in targeting amyloid buildup as a treatment for Alzheimer’s disease. However, Lilly acknowledges that other approaches are needed and expects results from a late-stage study of a tau-fighting drug next year.
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