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Eli Lilly Anticipates FDA Decision on Alzheimer's Treatment Donanemab by Year-End

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Eli Lilly Applies for FDA Approval of Alzheimer's Treatment Donanemab

Eli Lilly Seeks FDA Approval for Donanemab

Eli Lilly and Company announced on Monday that it has applied for full U.S. Food and Drug Administration (FDA) approval of its Alzheimer's treatment, donanemab. The company expects the FDA to make a decision by the end of the year. This application comes as Eli Lilly joins other pharmaceutical companies in the race to market new treatments for Alzheimer's disease. Earlier this month, the FDA approved Eisai and Biogen's drug, Leqembi, marking a significant milestone in Alzheimer's treatment.

Potential Expansion of Treatment Options

If the FDA approves Eli Lilly's donanemab, it would expand the treatment options for the more than 6 million Americans of all ages who have Alzheimer's disease. The announcement of the final results from an 18-month phase-three trial on the monthly antibody infusion donanemab was also presented by Eli Lilly at the Alzheimer's Association International Conference. These findings revealed that donanemab significantly slowed the progression of Alzheimer's in patients at the early stages of the disease, especially those with confirmed brain plaque associated with the disease. The positive results of the trial have garnered strong support from the Alzheimer's Association.

Positive Results Address FDA Concerns

The final results of the phase three trial address a concern that the FDA had previously raised when they rejected Eli Lilly's application for expedited approval of donanemab in January. At that time, the agency requested more data on patients who received the treatment for at least 12 months. The trial results demonstrated a 35% slower decline in memory, thinking, and daily activities in patients who received donanemab compared to those who received a placebo. Notably, patients in the earliest stages of the disease showed a 60% slower decline in cognitive function. These findings highlight the potential benefits of initiating treatment early.

Greater Benefits and Reduction in Disease Progression

Patients who took donanemab were almost 39% less likely to progress to the next stage of Alzheimer's disease during the trial. Additionally, almost half of the patients who received donanemab showed no disease progression a year after treatment began, compared to only 29% for those who did not receive the drug. More than half of the patients completed the treatment in the first year, and 72% completed it in 18 months, indicating the potential for success in clearing brain plaque.

Risks of Donanemab Treatment

While donanemab shows promise in slowing the progression of Alzheimer's, it also comes with risks. The treatment has been known to cause brain swelling and bleeding, which in some cases can be severe and even fatal. Three trial participants died from these side effects, according to Eli Lilly. Similar side effects have been observed in other Alzheimer's antibody treatments, such as Leqembi. Despite these risks, the potential benefits of donanemab in treating Alzheimer's are significant.

Big Pharma's Potential Impact on New Business

The application for FDA approval of Eli Lilly's Alzheimer's treatment, donanemab, and the positive results from the phase three trial have the potential to impact new businesses in the healthcare sector. Here's a "hot take" on how this news may influence the industry:

Increasing Treatment Options

The potential FDA approval of donanemab would expand the available treatment options for the millions of Americans with Alzheimer's disease. This could create opportunities for new businesses that specialize in providing and administering these cutting-edge treatments. As the demand for Alzheimer's treatments grows, there may be room for innovative startups to enter the market and offer unique services and solutions, such as personalized treatment plans, remote patient monitoring, or improved drug delivery methods.

Early Intervention Benefits

The trial results demonstrating the benefits of initiating treatment early could also have implications for new businesses. With a growing emphasis on early intervention to slow disease progression, there may be opportunities for companies that focus on early detection and diagnosis of Alzheimer's. This could include the development of advanced diagnostic tools, digital health solutions, or even specialized clinics dedicated to early Alzheimer's intervention.

Risks and Safety Measures

Despite the potential benefits, the risks associated with donanemab treatment, such as brain swelling and bleeding, cannot be overlooked. New businesses entering the Alzheimer's treatment market would need to prioritize patient safety and develop stringent safety protocols. Companies that specialize in patient monitoring, adverse event management, or predictive analytics for treatment outcomes could play a crucial role in ensuring the safe administration of donanemab and other similar treatments.

In conclusion, the potential FDA approval of Eli Lilly's donanemab and its positive trial results open up avenues for new businesses in the Alzheimer's treatment landscape. Opportunities may arise in providing innovative treatment services, early intervention solutions, and safety-focused services. However, businesses must be mindful of the risks associated with the treatment and prioritize patient safety to thrive in this evolving market.

Article First Published at: https://www.cnbc.com/2023/07/17/alzheimers-eli-lilly-expects-fda-decision-on-donanemab-by-year-end.html

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