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Eli Lilly’s Alzheimer’s Treatment Approved in China

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China’s medical regulator has approved Eli Lilly’s Kisunla, an Alzheimer’s treatment for early-stage disease, offering patients an additional therapeutic option after the approval of Leqembi, developed by Eisai and Biogen, earlier this year. This marks China’s entry into a select group of major markets—including the United States, Japan, and the UK—where Kisunla is approved, Eli Lilly announced on Tuesday.

Kisunla, like Leqembi, targets the clearance of beta-amyloid, a protein linked to Alzheimer’s disease, from the brain. In a late-stage clinical trial, Kisunla demonstrated a 29% reduction in the progression of memory and cognitive decline compared to a placebo. However, the treatment carries safety concerns, with reports of brain swelling in nearly 25% of patients and brain bleeding in approximately 33%, though most cases were deemed mild.

In response to these risks, Kisunla’s U.S. prescribing label includes the FDA’s strongest “boxed” safety warning, similar to Leqembi’s label. Lilly has addressed concerns by introducing a gradual dosing schedule, which has been shown to reduce the likelihood of severe brain swelling.

A key distinction between Kisunla and Leqembi lies in their dosing approach. Kisunla offers finite dosing, allowing patients to discontinue the treatment once brain scans confirm the absence of amyloid plaques, whereas Leqembi does not.

Kisunla is currently under review by the European Union’s drug regulator. In contrast, Leqembi was rejected by the EU earlier this year due to concerns that the risks of brain swelling outweighed its modest benefits in slowing cognitive decline.

According to the World Health Organization, Alzheimer’s is the leading cause of dementia, accounting for 60%-70% of cases globally.

 

Study Finds Link Between Brain Injuries and Increased Alzheimer’s Disease Risk

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New Study Links Traumatic Brain Injuries to Increased Alzheimer’s Disease Risk

Recent research from The Ohio State University Wexner Medical Center has provided compelling evidence that traumatic brain injuries (TBI) may significantly increase the likelihood of developing Alzheimer’s disease. By utilizing both animal models and human brain tissue samples, scientists have identified a potential link between TBIs and the accumulation of harmful proteins in the brain, which are associated with cognitive decline. Central to this discovery is the role of a protein called BAG3, which is crucial for the removal of toxic proteins. The study proposes that enhancing BAG3 levels could be a promising strategy to mitigate Alzheimer’s risk in individuals who have suffered TBIs.

Every year, approximately 2.5 million people experience TBIs, with a notable portion facing heightened risk for Alzheimer’s disease as they age. Led by Dr. Hongjun “Harry” Fu, Assistant Professor of Neuroscience, the research team aimed to explore the molecular pathways connecting TBI to Alzheimer’s. Their findings revealed that TBIs significantly increase the presence of hyperphosphorylated tau proteins in the brain. These tau proteins are known to disrupt normal cellular function and are key contributors to the neurodegenerative processes seen in Alzheimer’s disease. The research highlights how TBIs can create a perfect storm for cognitive decline by facilitating the conditions necessary for protein aggregation.

The study also emphasizes the importance of BAG3 in maintaining brain health following injury. Researchers discovered that BAG3 levels decrease after a TBI, leading to an increased accumulation of tau proteins in neurons. This depletion can exacerbate cognitive issues and accelerate the progression of neurodegenerative diseases. However, the team’s innovative approach to gene therapy aimed at boosting BAG3 levels demonstrated promising results. By restoring BAG3 expression, they observed improvements in brain function and a reduction in the accumulation of toxic proteins, suggesting a potential therapeutic pathway for preventing Alzheimer’s disease.

The implications of this research are significant, particularly as the incidence of TBIs continues to rise, especially among athletes and individuals involved in high-risk occupations. By focusing on BAG3 as a target for intervention, the study opens the door for developing novel strategies to protect brain health in those who have experienced TBIs. Future research will be critical to further elucidate the mechanisms at play and to determine the feasibility of implementing BAG3-targeted therapies in clinical settings. Ultimately, this study not only enhances our understanding of the relationship between brain injuries and Alzheimer’s but also offers hope for new preventive measures against cognitive decline.

GLP-1s Beyond Weight Loss and Diabetes: Exploring New Therapeutic Frontiers

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The potential health benefits of GLP-1 (glucagon-like peptide-1) drugs, known for their use in weight loss and diabetes management, are expanding. Novo Nordisk recently revealed that its GLP-1 drug liraglutide may slow Alzheimer’s disease progression by protecting the brain, according to new mid-stage trial data. Additionally, another study indicated that semaglutide, found in Novo Nordisk’s Wegovy and Ozempic, could aid smoking cessation. These GLP-1 treatments mimic gut hormones to suppress appetite and regulate blood sugar, and researchers believe they might also reduce inflammation and treat other conditions.

However, more extensive research and longer trials are necessary before regulators can approve these drugs for additional uses. The FDA took a significant step in March by approving Wegovy to reduce the risk of serious heart complications. This could increase pressure on insurers to cover these treatments, which often cost around $1,000 per month. Here are other conditions GLP-1s are being tested for:

1. Cardiovascular Health:
• Wegovy has been shown to reduce the risk of heart attack, stroke, and death from cardiovascular causes by 20% in obese patients with heart disease.
• It also alleviated cardiovascular symptoms in patients with obesity, diabetes, and heart failure.
• Eli Lilly’s tirzepatide (in Zepbound and Mounjaro) is being tested in a late-stage trial for obesity and heart failure, expected to conclude this month.

2. Chronic Kidney Disease:
• Novo Nordisk’s Ozempic slowed chronic kidney disease progression in diabetes patients, reducing the risk of death and major cardiac events by 24%.
• Eli Lilly is also studying tirzepatide for obesity and chronic kidney disease in a trial ending in 2026.

3. Fatty Liver Disease:
• Eli Lilly’s Zepbound significantly improved fatty liver disease outcomes in a mid-stage trial.
• Novo Nordisk and other companies like Zealand Pharma, Viking Therapeutics, and Altimmune are also studying GLP-1 treatments for fatty liver disease.

4. Sleep Apnea:
• Zepbound has shown promise in resolving moderate to severe obstructive sleep apnea, and the FDA is reviewing it for this use.

5. Alzheimer’s Disease:
• Novo Nordisk is investigating semaglutide in late-stage trials for Alzheimer’s disease.

6. Addiction:
• Studies are exploring GLP-1s’ potential to curb addictive behaviors, including nicotine and alcohol use. Novo Nordisk is planning a study to see if semaglutide can reduce alcohol consumption.

The broadening scope of GLP-1 applications underscores their potential as versatile treatments for various conditions beyond weight loss and diabetes.