Latest news with #Kisunla
Time of India
2 days ago
- Health
- Time of India
Can cancer drugs treat Alzheimer's? New study thinks so
Alzheimer's disease, a progressive neurodegenerative disorder that primarily affects memory and cognitive functions, is the most common cause of dementia, accounting for 60-70% of dementia cases. As per Alzheimer's Association, in 2025, global Alzheimer's statistics indicate a significant prevalence of the disease, with projections estimating that over 7 million Americans will be living with Alzheimer's dementia. Globally, it is estimated that someone develops dementia every three seconds, and the number of people living with dementia is expected to reach 78 million by 2030. The progressive neurodegenerative disorder, long considered a therapeutic dead end, may soon find some hope of cure in an unlikely ally: cancer drugs. Recent research reveals that several oncology medications, originally designed to fight tumors, have shown promise in targeting key pathways of Alzheimer's disease (AD), from protein aggregation to neuroinflammation and metabolic dysfunction. Let's delve deeper into the newest discovery of the silver lining. The medical breakthrough: Scientists are exploring cancer drugs as a potential way to tackle Alzheimer's disease, given that the options for treatment are quite limited. As cases of Alzheimer's continue to rise in the U.S. and around the world due to an aging population, there still isn't a cure. Efforts to create new treatments that actually slow the disease's progression have mostly fallen short. Currently, only two drugs, Leqembi and Kisunla, are approved by the FDA to slow down early Alzheimer's, but their effectiveness is very limited. Many pharmaceutical companies have even stopped developing Alzheimer's drugs after unsuccessful trials, while others are experimenting with existing medications, including popular weight loss drugs. Researchers at the University of California, San Francisco, have taken a different approach. They searched through a database of over 1,300 various drugs, like antipsychotics and chemotherapy drugs, to find ones that could be repurposed for Alzheimer's treatment. Their study, published in the journal Cell , highlighted two cancer drugs that showed promise in reducing Alzheimer's risk. When tested together on mice, these drugs appeared to slow or even reverse Alzheimer's symptoms. One drug is typically used for breast cancer, and the other works against colon and lung cancer. Alzheimer's is known to cause significant changes in gene expression in the brain, which can disrupt brain function and lead to memory loss. From their database, fewer than 90 drugs successfully reversed markers related to Alzheimer's in human brain cells. Of these, five drugs seemed particularly effective in lowering Alzheimer's risk for actual patients, and the researchers focused on two FDA-approved cancer drugs to test in mice. According to the findings, letrozole, a breast cancer drug, appeared to influence gene expression in nerve cells, while irinotecan, used for colon and lung cancer, affected glial cells, which support the nervous system. Alzheimer's can damage nerve cells and trigger an overgrowth of glial cells, leading to brain inflammation. Interestingly, past studies have shown that breast cancer patients on letrozole had a lower chance of developing Alzheimer's, and colorectal cancer survivors treated with irinotecan also showed decreased risk, adding to the excitement around these findings. The groundbreaking findings: Researchers have been testing a combination of two cancer drugs in mice and found some promising results: the combo reversed brain degeneration and improved memory in mice showing signs of Alzheimer's. However, because what works in mice doesn't always work in humans, they plan to test these drugs in a clinical trial with Alzheimer's patients. Dr. Yadong Huang, a co-author of the study and a neurology professor at UCSF, noted the advantages of repurposing existing drugs: 'Developing a new drug can take hundreds of millions, or even billions, of dollars, and on average takes more than 10 years. For this repurposed drug, usually, it just takes two or three years, and then you can go to the clinical trial, and the cost is much, much lower.' Despite this progress, he acknowledged, as reported by NBC News, 'We still haven't generated or produced any very effective drugs that can really slow down dramatically the cognitive decline. ' Alzheimer's remains a complex disease, and its exact cause is still a mystery. Currently, it isn't clear why these cancer drugs might help with Alzheimer's. One idea is that the breast cancer drug reduces estrogen production, which controls many genes. Another theory is that the colon and lung cancer drug might reduce inflammation in the brain by stopping glial cells from multiplying. Dr. Melanie McReynolds, a biochemistry assistant professor at Pennsylvania State University, who wasn't involved in this study, added another angle. Her research suggests that another cancer drug can help Alzheimer's by regulating glucose metabolism, which is how cells generate energy. 'With aging, with stress, with diseases, that line of communication is disrupted,' she explained. She believes the drug combo could reverse metabolic decline, calling it 'the secret for contributing to better outcomes with Alzheimer's. ' What's ahead: Cancer drug repurposing opens a transformative chapter in Alzheimer's treatment, where repurposing anticancer agents allows researchers to exploit existing toxicity and pharmacokinetic data, potentially accelerating human testing and reducing development costs. While these findings are exciting, the potential side effects need to be carefully considered. Letrozole can cause hot flashes, and irinotecan may lead to severe diarrhea. 'These drugs have huge side effects, so you need to always balance and figure out whether those types of side effects would be amenable to somebody with Alzheimer's,' Sirota cautioned. 'It's not that it's a slam dunk.' Reduced risk of Alzheimer's disease linked to target protein for diabetes, as per a study
NBC News
3 days ago
- Health
- NBC News
Could cancer drugs be the future of Alzheimer's treatment?
With few treatments available to stop or reverse Alzheimer's disease, scientists have turned to cancer drugs as a potential means of walking back cognitive decline. Alzheimer's cases are rising in the United States and worldwide due to an aging population, but there is no cure for the disease. Attempts to develop new treatments that slow the disease's progress, rather than lessen symptoms, have frequently failed. Only two drugs — the antibody therapies Leqembi and Kisunla — are currently approved by the Food and Drug Administration to slow the progression of early Alzheimer's, and scientists say their benefits are limited. Some pharmaceutical companies have halted or abandoned their Alzheimer's drug development programs because of unsuccessful trials. Others are trying to use existing medications, including popular weight loss drugs, to combat Alzheimer's. With that in mind, researchers at the University of California, San Francisco conducted a broad search for drugs that could be repurposed to treat the condition — in theory, reducing the time in which the drugs could be made available to patients. They scoured a database of more than 1,300 drugs of various classes, including antipsychotics, antibiotics, antifungals and chemotherapy drugs. Then, they looked at how those drugs affected gene expression. Their new study, published Monday in the journal Cell, identified two cancer drugs as the best candidates to lower Alzheimer's risk in patients. When combined, the drugs seemed to slow or reverse Alzheimer's symptoms in mice. One of the drugs is normally used to treat breast cancer, while the other is effective against colon and lung cancer. Alzheimer's disease is associated with significant changes in the way genes are expressed in the brain, leading to the increased production of certain proteins and the decreased production of others. These imbalances may disrupt brain function and contribute to symptoms like memory loss. Fewer than 90 drugs in the researchers' database reversed the expression of signature Alzheimer's-related genes in human brain cells. And five drugs in particular seemed to lower the risk of Alzheimer's in actual patients, based on electronic medical records. The authors ultimately selected two of those drugs, both approved by the FDA to treat cancer, to test in mice. 'We didn't expect cancer drugs to come up' as the most promising, said Marina Sirota, a co-author of the study and interim director of the UCSF Bakar Computational Health Sciences Institute. The authors said the breast cancer drug letrozole seemed to change gene expression in nerve cells. And the colon and lung cancer drug irinotecan seemed to change gene expression in glial cells, which support the nervous system. Alzheimer's can destroy nerve cells and cause glial cells to proliferate, creating inflammation in the brain. In a 2020 study, breast cancer patients who received letrozole were less likely to develop Alzheimer's than patients who did not receive the drug. Colorectal cancer survivors treated with irinotecan also had a decreased Alzheimer's risk, according to a 2021 study. After testing the drugs in mice, the study authors found that the two-drug combo reversed brain degeneration and improved memory in mice that had developed hallmarks of Alzheimer's as they aged. Because results in mice often don't translate to humans, the researchers hope to test the drugs in a clinical trial with Alzheimer's patients. 'Developing a new drug can take hundreds of millions, or even billions, of dollars, on average take more than 10 years. For this repurposed drug, usually it just takes two or three years, and then you can go to the clinical trial and the cost is much, much lower,' said Dr. Yadong Huang, a co-author of the study and professor of neurology at UCSF. 'We still haven't generated or produced any very effective drugs that can really slow dramatically the cognitive decline,' he added. Part of the difficulty in developing drugs for Alzheimer's is the complexity of the disease. Its exact cause is largely unknown. For now, the authors said, it's unclear exactly why the cancer drugs seem to work against Alzheimer's. One theory is that the breast cancer drug blocks the production of estrogen, a hormone that controls the expression of a large number of genes. The colon and lung cancer drug may also block inflammation in the brain by preventing the proliferation of glial cells — though Huang said there are other possibilities. Dr. Melanie McReynolds, an assistant professor of biochemistry at Pennsylvania State University, who was not involved in the study, offered another theory. Her research has suggested that a different type of cancer drug could help treat Alzheimer's by regulating glucose metabolism, the process by which cells make energy. McReynolds said the process is necessary for various brain cells to communicate with each other. 'With aging, with stress, with diseases, that line of communication is disrupted,' she said. McReynolds said the drug combo tested in the new study might reverse metabolic decline — what she called 'the secret for contributing to better outcomes with Alzheimer's.' But assessing how Alzheimer's patients tolerate the combination of cancer drugs will be important. Letrozole can cause hot flashes and irinotecan can cause severe diarrhea. Both drugs can lead to nausea and vomiting. 'These drugs have huge side effects, so you need to always balance and figure out whether those types of side effects would be amenable to somebody with Alzheimer's,' Sirota said. 'It's not that it's a slam dunk.'
Yahoo
15-07-2025
- Business
- Yahoo
Eli Lilly (LLY) Secures FDA Label Update for Alzheimer's Disease Treatment
Eli Lilly and Company (NYSE:LLY) is one of Goldman Sachs' top healthcare stock picks. On July 9, the company confirmed the approval by the US Food and Drug Administration of a label update for its once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD). A doctor holding a microscope in front of a laboratory sample of healthcare products. The new label significantly reduces the incidence of amyloid-related amyloid-related imaging abnormalities with edema/effusion. The company expects the new label update for Kisunla to enhance the way healthcare professionals evaluate treatment options for parents. 'This update underscores our unwavering commitment to patient safety and the advancement of Alzheimer's disease treatment by potentially mitigating the risk of ARIA-E,' stated Brandy Matthews, MD, FAAN, Lilly's Vice President of Global & US Medical Affairs for Alzheimer's Disease. The FDA has approved a more gradual titration that reduces the incidence of ARIA-E by 41% at 24 weeks and by 35% at 52 weeks compared to the original dosing schedule. It should result in lower rates of ARIA-E without compromising Kisunla's ability to reduce amyloid plaque or Kisunla's once-monthly dosing. Eli Lilly will now offer patients and the care team confidence in the safety of Kisunla in reducing amyloid. Eli Lilly and Company (NYSE:LLY) is a pharmaceutical company that discovers, develops, manufactures, and sells human healthcare products. It specializes in a wide range of therapeutic areas, including diabetes, oncology, immunology, and neuroscience. While we acknowledge the potential of LLY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 11 Best Green Energy Penny Stocks to Buy Right Now and 10 Most Popular AI Penny Stocks to Buy According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-07-2025
- Health
- Yahoo
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, July 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology.1,2 In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. "We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients," stated Brandy Matthews, MD, FAAN, Lilly's Vice President of Global & US Medical Affairs for Alzheimer's Disease. "This update underscores our unwavering commitment to patient safety and the advancement of Alzheimer's disease treatment by potentially mitigating the risk of ARIA-E." The new recommended dosing regimen involves a more gradual titration, and the TRAILBLAZER-ALZ 6 study significantly lowered the incidence of ARIA-E by 41% at 24 weeks and by 35% at 52 weeks versus the original dosing schedule. ARIA-E is a side effect of amyloid plaque-targeting therapies, including Kisunla. ARIA-E is usually asymptomatic, although serious and fatal events can occur. The new dosing recommendation differs from the original dosing by shifting a single vial from the first dose to the third dose, delivering the same amount of Kisunla by week 24. This resulted in lower rates of ARIA-E without compromising Kisunla's ability to reduce amyloid plaque or Kisunla's once-monthly dosing with the potential for limited-duration treatment based on amyloid plaque removal to minimal levels.3-6 Key findings from the TRAILBLAZER-ALZ 6 study, which supports this label update, included: The primary endpoint of the study was the proportion of participants with any occurrence of ARIA-E by week 24. The results showed the incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the original dosing regimen, a 41% lower relative risk.7 At week 52, the incidence of ARIA-E was 16% in patients receiving the modified titration compared with 25% for those receiving the original dosing regimen, a 35% lower relative risk. Including asymptomatic radiographic events at week 52, ARIA, ARIA-E, and ARIA-H were observed in 29%, 16%, and 25% of patients receiving the modified titration dosing. ARIA-E and ARIA-H are different types of amyloid-related imaging abnormalities (ARIA). ARIA with edema is characterized as ARIA-E and ARIA with hemosiderin deposition is characterized as ARIA-H. Patients on the modified titration experienced a reduction of amyloid plaque and P-tau217 comparable to patients receiving the original dosing regimen. As observed using amyloid PET at the primary endpoint of 24 weeks, amyloid plaque levels in patients on the modified titration of donanemab in TRAILBLAZER-ALZ 6 were reduced on average 67% from baseline compared to 69% for patients on the original dosing regimen.7,8 No new adverse reactions were identified in this study, although higher rates of hypersensitivity reactions and infusion-related reactions were observed. "This updated dosing strategy is a meaningful advancement for patients and their care teams," said Elly Lee, MD, Chief Medical Officer and Principal Investigator, Irvine Center for Clinical Research. "By significantly reducing the risk of ARIA-E, we can offer patients and care teams greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid." The U.S. FDA approved Kisunla in July 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data. The study demonstrated that Kisunla significantly slowed cognitive and functional decline in patients who were less pathologically advanced in their disease by up to 35% and by 22% in the overall study population compared to placebo at 18 months.9 Kisunla reduced the risk of progressing to the next clinical stage of disease by 37% over the same period.3 Cognitive and functional decline was characterized by more severe memory and thinking problems, more trouble with daily activities, and a greater need for help from caregivers.3,10 Please see the INDICATION AND SAFETY SUMMARY WITH WARNINGS below. Lilly Support Services for Kisunla is dedicated to assisting patients throughout their treatment journey with Kisunla. This free program provides essential services, including coverage determination assistance, care coordination, nurse navigator support, and personalized resources. For more information about Lilly Support Services and Kisunla, visit or call 1-800-LillyRx (1-800-545-5979). About Kisunla™ (donanemab)Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an amyloid-targeting therapy for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Kisunla (donanemab-azbt) injection for intravenous use is available as a 350 mg/20 mL single-dose vial. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions. About TRAILBLAZER-ALZ 6 study and the TRAILBLAZER-ALZ programTRAILBLAZER-ALZ 6 (NCT05738486) is a Phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan.7 These study results were published in Alzheimer's and Dementia. About TRAILBLAZER-ALZ 2 studyTRAILBLAZER-ALZ 2 (NCT04437511) is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (MCI or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA). Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, evaluating the potential to reduce the risk of progression to symptomatic AD in participants with preclinical AD; and TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China, Korea, Taiwan, and other geographies. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla™ (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease. Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures. Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk. Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion. Other common side effects Headache Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or Before you receive Kisunla, tell your healthcare provider: About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby. How to receive KisunlaKisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes. Learn moreFor more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you. DN CON BS APP Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY PP-DN-US-0632 07/2025 © Lilly USA, LLC 2025 ALL RIGHTS RESERVED. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a treatment for people with early symptomatic Alzheimer's disease, Kisunla dosing regimens and the prevalence of ARIA-E, and future readouts, presentations, and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References Kisunla (donanemab-azbt). Prescribing Information. Lilly USA, LLC. Kisunla (donanemab-azbt). Medication Guide. Lilly USA, LLC. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239. Ross EL, Weinberg MS, Arnold SE. Cost-effectiveness of Aducanumab and Donanemab for Early Alzheimer Disease in the US. JAMA Neurol. 2022;79(5):478-487. doi:10.1001/jamaneurol.2022.0315. Boustani M, Doty EG, Garrison LP Jr, et al. Assessing the Cost-effectiveness of a Hypothetical Disease-modifying Therapy With Limited Duration for the Treatment of Early Symptomatic Alzheimer Disease. Clin Ther. 2022;44(11):1449-1462. doi:10.1016/ Mattke S, Ozawa T and Hanson M. Implications of Treatment Duration and Intensity on the Value of Alzheimer's Treatments. Clinical Trials on Alzheimer's Disease. Oct. 24-27, 2023. Wang H, Monkul Nery ES, Ardayfio P, et al. (2025). 21(4). Data on File. Lilly USA, LLC. DOF-DN-US-0069. Data on File. Lilly USA, LLC. DOF-DN-US-0053. 2024 Alzheimer's disease facts and figures. Alzheimers Dement. 2024 May;20(5):3708-3821. doi: 10.1002/alz.13809. Epub 2024 Apr 30. PMID: 38689398; PMCID: PMC11095490. Refer to: Gina Goodenough; 463-304-2167 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
09-07-2025
- Health
- Reuters
US FDA approves gradual dosing for Lilly Alzheimer's drug
July 9 (Reuters) - The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's (LLY.N), opens new tab Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous type of brain swelling, the company said on Wednesday. Kisunla, given as a monthly infusion, is part of a class of drugs designed to clear an Alzheimer's-related protein called beta amyloid from the brain. It was approved by the FDA just over a year ago for adults with early-stage Alzheimer's after a study showed it slowed progression of memory and thinking problems by 29% compared with a placebo. The FDA placed its strongest "boxed" safety warning on Kisunla's prescribing label, flagging the risk of potentially life-threatening brain swelling and bleeding. Lilly presented study data last year showing that after 24 weeks of treatment, 24% of patients given the standard Kisunla regimen experienced a side effect called ARIA-E, a kind of brain swelling, compared with 14% of those on more gradual dosing. The altered schedule did not compromise Kisunla's ability to reduce amyloid brain plaques, the company said. The new dosing recommendation is to start with a single vial, adding a vial each month until reaching the full four-vial dose at month four. The previous schedule was for two vials monthly until moving to the full dose at month four. "The update will help healthcare professionals in their evaluation of treatment options for patients and their benefit/risk discussions," said Dr. Brandy Matthews, Lilly's vice president for global and U.S. medical affairs for Alzheimer's disease. Kisunla competes with Eisai (4523.T), opens new tab and Biogen's (BIIB.O), opens new tab amyloid-lowering drug Leqembi, which also carries a boxed warning about safety risks including ARIA-E. Adoption of the drugs has been slow due to the complexities involved with their use, including the need for extra diagnostic tests and regular brain scans to monitor for side effects. Both Kisunla and Leqembi are currently being studied for treating people diagnosed with Alzheimer's who have not yet begun to show symptoms of the brain disease. More than 6 million Americans have Alzheimer's disease, according to the Alzheimer's Association
