Eli Lilly & Co. has seen a rise in its shares after its experimental Alzheimer’s drug, donanemab, showed promising results in a final-stage trial. A panel of independent advisors to the FDA recently recommended the drug for full approval in the U.S. The approval of this drug would expand treatment options for the over 6 million Americans diagnosed with Alzheimer’s, which is the fifth-leading cause of death for adults over 65.
The advisory panel unanimously agreed that donanemab is effective in treating Alzheimer’s patients in the early stages of the disease. However, more data is needed to assess its effectiveness in different patient groups, such as Black and Hispanic individuals. Despite some safety concerns, the benefits of the drug were deemed to outweigh the risks by the advisors, highlighting the urgent need for new treatment options for Alzheimer’s patients.
Both donanemab and another drug, Leqembi from Biogen, target amyloid plaque in the brain to slow the progression of Alzheimer’s. However, these drugs are not cures and can pose risks such as brain swelling and bleeding in some patients. Eli Lilly faced setbacks in gaining approval for donanemab, including last-minute safety reviews by the FDA. The efficacy of donanemab was tested on over 1,700 patients, showing a 29% reduction in disease progression compared to a placebo.
Although donanemab has shown promise, it is associated with brain swelling and bleeding in a significant number of trial participants. It is expected that the drug’s label will carry a strong warning about these risks, especially for individuals with a specific gene variant. Despite these risks, the potential benefits of the drug, particularly for patients with low-to-medium levels of tau protein in the brain, are significant in slowing down the progression of Alzheimer’s.
The future commercial adoption of donanemab may be limited compared to Leqembi, as the latter is currently more convenient to administer. However, ongoing research and advancements in treatment methods may improve the accessibility and convenience of donanemab in the future. With the urgent need for effective Alzheimer’s treatments, donanemab represents a significant advancement in the field and offers hope to millions of patients suffering from this debilitating disease.
In conclusion, Eli Lilly’s Alzheimer’s drug, donanemab, has shown promise in slowing down the progression of the disease in patients at the early stages. Despite some safety concerns, the drug’s benefits outweigh the risks, according to FDA advisors. With the potential for full approval in the U.S., donanemab could provide much-needed treatment options for the millions of Americans living with Alzheimer’s. Ongoing research and improvements in treatment methods are essential to maximize the benefits of this drug and improve the lives of Alzheimer’s patients worldwide.
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