Latest news with #BrandyMatthews
Atlantic
a day ago
- Health
- Atlantic
The Future of Alzheimer's Diagnosis Is Now
A patient enters her general practitioner's office for a routine checkup. She is 65 years old, and—knock on wood—in good health: walking outside every morning, eating a thoughtful diet, and reading voraciously. All of this she naturally tells her doctor during the visit. However, lately she's been forgetting things here and there. Nothing major, she thinks. It's just a normal part of getting older. So this small detail she keeps to herself. But by holding on to that detail, the patient is also putting off a conversation that could change the course of her life as well as her family's. Memory change is not always a part of normal aging, with more than 7 million adults living with Alzheimer's disease in the United States—a number that is expected to almost double in the next few decades. The fear that talking about it will lead to a road of invasive procedures, life-changing diagnoses, and painful choices is all too common. However, new scientific developments in diagnostics have been made so medical experts can help diagnose or rule out Alzheimer's disease sooner, and more easily, than ever before with a simple blood test. In this new era, patients can rule out the disease as a diagnosis or talk to their doctors about care options and plan with their families if they receive a diagnosis. When patients receive a timely and accurate diagnosis, this opens up the opportunity for them to make plans for the future Brandy Matthews Vice President of Global and U.S. Medical Affairs for Eli Lilly and Company 'We have to overcome this barrier of stigma,' says Brandy Matthews, M.D., FAAN, vice president of global and U.S. medical affairs for Alzheimer's disease at Eli Lilly and Company, 'and then the reinforcement of the myths [so] that people will raise their hand when they begin to experience changes in their memory and thinking.' In addition to the laboratory developed tests that are already available and developed under the Clinical Laboratory Improvement Amendments (CLIA) to aid in Alzheimer's disease diagnosis, the FDA recently cleared the first in vitro diagnostic (IVD) blood biomarker test. These tests can be administered to symptomatic patients as part of a cognitive workup. 'The fact that there's been a recent FDA clearance for a blood biomarker in Alzheimer's disease is really critical and really big and I think will be a sort of a monumental shift in how we diagnose Alzheimer's disease,' says Anthony 'Nino' Sireci, M.D., MSc, senior vice president of clinical biomarkers, laboratories and diagnostics at Eli Lilly and Company. The work of developing new technology to diagnose a disease is painstaking and slow, but these breakthroughs are essential for patients. These advances not only offer hope to millions but also provide researchers like Matthews and Sireci with a profound sense of purpose. 'When patients receive a timely and accurate diagnosis, this opens up the opportunity for them to make plans for the future, to engage in lifestyle modifications, and to explore options for therapies that may target their symptoms or the underlying pathology of the disease,' says Matthews. Way back in 1906, the German neuropathologist Alois Alzheimer identified what he called 'an unusual disease of the cerebral cortex' marked by symptoms of memory loss. Using newly available technology, he identified two key pathological proteins in the neurons of his patients' brain cells: Beta-amyloid and tau. Beta-amyloid and tau are proteins produced naturally in the body. In patients with Alzheimer's disease, beta-amyloid starts to clump together, creating plaques between brain cells, while tau twists together into tangles inside brain cells. 'They are involved in a cascade of changes that happen in the brain, presumably initially with amyloid plaque accumulation, followed by tau tangle accumulation, leading to the dysfunction of the brain cells and then eventually neurodegeneration or shrinking of the brain. That results in the symptoms of Alzheimer's disease,' says Matthews. To be able to have a data-driven conversation, I think, is going to be pretty big in ensuring, number one, that patients are appropriately triaged Anthony 'Nino' Sireci, M.D. Senior Vice President of Diagnostics Development at Lilly Beta-amyloid plaques and tau tangles are the cause of the disease, but for nearly a century following their initial discovery, they could be identified only posthumously. This changed in 2002, when scientists identified amyloid plaque in the brain of a patient with a PET scan for the first time, using an imaging agent approved by the FDA in 2012. In 2022, the FDA cleared its first biomarker test measuring the presence of beta-amyloid in cerebrospinal fluid (CSF), drawn during a lumbar puncture (also known as a spinal tap). 'Modified fragments of those proteins are released into the cerebrospinal fluid,' says Sireci. 'And so those become some of the biomarkers that you measure in CSF.' While effective tools and necessary parts of the diagnostic process, PET scans and spinal taps are invasive and not always readily available, depending on where patients are located. This is where blood biomarkers come in, because beta-amyloid and tau aren't released only into CSF. 'Some of them actually leak out into the blood in super small quantities,' says Sireci. 'And that's what we use as the basis for identification of blood biomarkers in patients with Alzheimer's disease.' The traces found in these tests are smaller and harder to identify than the ones found in CSF. One challenge has been innovating over years to make blood test more closely resemble CSF – a major breakthrough developed over years of challenging work. And such tests require patients access and provider experience. In an ideal world, a simple blood sample could be collected at any doctor's office, even in rural or underserved communities, and sent to a major reference lab where, combined with the patient's initial cognitive assessment, it could provide information to help the treating physician to diagnose Alzheimer's disease without the need for additional confirmatory testing. That would vastly expand access to timely diagnosis. But there is still a lot of work to do between the clearance of a medical technology and its implementation. 'The obstacles now are not scientific,' says Sireci. 'Medicine is a logistical effort.' Are the [diagnostic] assay themselves robust enough that physicians feel confident in the results and confident in how they interpret them? That's really big. Anthony 'Nino' Sireci, M.D. Senior Vice President of Diagnostics Development at Lilly 'It's implementation,' he says. 'Are the [diagnostic] assay themselves robust enough that physicians feel confident in the results and confident in how they interpret them? That's really big.' But with any new diagnostic tools come questions. Are physicians educated in how to understand the results? Are they confident in those results? And once they are, are they actually able to order the test at scale from high quality labs? It's about quality and it's about access. And that's only on the medical side. What about patients? Will insurers reimburse the tests so that patients are not faced with high out-of-pocket costs? Will patients embrace them? Sireci is optimistic about both possibilities. A recent survey by the Alzheimer's Association found that 91 percent of patients would want a blood biomarker test if it were made available to them. A readily available blood biomarker test gives doctors and patients a tool to aid in accurate and timely diagnosis. That patient who walked into her general practitioner's office? She would undergo a routine cognitive exam (a recommended standard for all patients 65 and older). She would have an honest conversation with her doctor about changes she might be perceiving in her brain function, however slight. And if the doctor thought it was necessary, a referral to a specialist for a simple blood test would be administered to help inform next steps. Then, unlike in the decades when Alzheimer's disease could be diagnosed only symptomatically or after an invasive procedure, the doctor would lead her in an informed, fact-based discussion—right away. From that conversation, the patient could undergo a PET scan or CSF testing to confirm or rule out the diagnosis if necessary. 'To be able to have a data-driven conversation, I think, is going to be pretty big in ensuring, number one, that patients are appropriately triaged,' says Sireci, 'but also [that] they're not waiting years for a diagnosis, which unfortunately is what's happening today.' We're moving the needle for patients and giving physicians another very powerful tool to combat this disease. Anthony 'Nino' Sireci M.D., Senior Vice President of Diagnostics Development at Lilly This is crucial because Alzheimer's is a progressive disease. Timing is critical. The earlier a patient is diagnosed, the more time they have for planning, which could include treatment options a patient has available to them. They can set themselves up for counseling, talk to their families, and could choose to begin medical intervention. 'We've learned over time that initiating therapy in the earlier stages of disease can have greater impact,' says Matthews. 'And even within those early symptomatic stages of disease, there's evidence, across a class of medicines, that the earliest stages of early symptomatic Alzheimer's disease may demonstrate the greatest benefit of new therapies.' For Sireci, who has experience with Alzheimer's disease both as a doctor and as the family member of a patient, the most gratifying aspect of his research is knowing that it can help shorten what he calls the 'diagnostic odyssey.' 'Even if that just means getting the conversation to happen for the physician faster than it would've, then I'm happy,' says Sireci. 'That's a really big deal. We're moving the needle for patients and giving physicians another very powerful tool to combat this disease.' The Future of Alzheimer's Diagnosis Is Now Hear more from Brandy Matthews, Vice President of Global and U.S. Medical Affairs at Eli Lilly and Company, on the future of Alzheimer's diagnosis. learn more
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
