The FDA has granted accelerated approval for Eisai/Biogen's new Alzheimer's drug Leqembi, which is the second medication in a new category targeting the fundamental pathology of Alzheimer's disease. Earlier in 2021, Eisai/Biogen had launched the controversial Alzheimer's drug Aduhlem (aducanumab), which was criticized for its high price, efficacy, and safety. Leqembi has a list price of $26,500 per year, which could make it a profitable drug. "Patients who are in the early stages of the disease and their caregivers now have a new treatment option to consider with their physicians. Our primary focus is on working with Eisai to make Leqemi available to patients who could benefit from this treatment as soon as possible," says Christopher A. Viehbacher, President and Chief Executive Officer of Biogen.
"After receiving this Accelerated Approval, we will concentrate on providing essential information on the correct usage of Leqembi to healthcare professionals," says Haruo Naito, Eisai's Chief Executive Officer. "Eisai will also collaborate with various payers to ensure access to Leqembi, offer a patient support program, and endeavor to complete submission for traditional approval as soon as possible to serve more people with early Alzheimer's disease."
"Leqembi was approved through the Accelerated Approval pathway, which allows the FDA to approve drugs for severe conditions where there is an unmet medical need, and the drug shows an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The FDA says that the results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been published, and the agency anticipates receiving the data soon," the FDA says. "Alzheimer's disease significantly impairs the lives of those affected by it and has devastating effects on their loved ones," says Billy Dunn, MD, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. "This treatment option is the most recent therapy that aims to target and impact the underlying disease process of Alzheimer's, rather than just treating the disease's symptoms."
To ensure your health and the health of others, here are five early signs of Alzheimer's according to doctors. Don't miss out.
Difficulty with Memory and Confusion: Possible Signs of Alzheimer's Disease
Alzheimer's disease is a progressive brain disease that can cause memory loss and decline in daily function. As neuropsychiatrist Brian Appleby, MD explains, age is the biggest risk factor, and one-third of people older than 85 will experience it. In most cases, it is not the patient who picks up on the signs of Alzheimer's, but a loved one usually notices it first.
According to Douglas Scharre, MD, the early signs of Alzheimer's can vary greatly and include difficulty communicating, word finding, challenges with complex tasks, withdrawal, lack of concentration, or an inability to plan or organize. It is important to be aware of these signs and to seek medical attention if they persist, as early diagnosis and treatment can help slow cognitive decline.
Remember, it is always better to be safe than sorry. If you notice any of these signs in yourself or a loved one, it's crucial to speak to a healthcare professional.
Impaired Judgment
Early signs of Alzheimer's can include impaired judgment, particularly in the area of finances. For many older people who live apart from their loved ones or children, there may be no one around to notice if bills go unpaid or if there is unusual spending activity. "That financial decision-making safety net may have been weakened," says Carole Roan Gresenz, Interim Dean at Georgetown University's School of Nursing and Health Studies. "We haven't been able to visit, and while technology can provide some help, it's not the same as sitting next to people and reviewing their checking account with them."
In fact, serious financial problems can often be the first sign of cognitive decline. "It's not uncommon at all for us to hear that one of the first signs that families become aware of is around a person's financial dealings," says Beth Kallmyer, Vice President for Care and Support at the Alzheimer's Association.
Language Issues
Language difficulties, including verbal and written issues, may indicate the onset of Alzheimer's disease. According to the University of California San Francisco Memory and Aging Center, language functioning is typically preserved in the early stages of Alzheimer's disease, but it may decline substantially in the mid to late stages. Individuals with Alzheimer's disease often have problems with language expression, word fluency, and object naming.
While syntax and language comprehension are usually preserved in the early stages, speech may become halting in the later stages due to word-finding difficulties. Patients may have trouble speaking in full sentences because they struggle to find the right words. Writing skills may also be compromised, and speech comprehension may be significantly impaired during the end-stage of the disease.
Misplacing Items
Misplacing items frequently could indicate the onset of Alzheimer's disease. According to Johns Hopkins Medicine, it is common to occasionally misplace things or put them in the wrong spot. However, the inability to recall where missing items are, placing things in strange locations, and believing without proof that someone has taken them are all warning signs of the disease. It's important to speak to a healthcare provider if you or a loved one are experiencing these symptoms.
Struggling with Routine Tasks and Disorientation
A common sign of Alzheimer's is difficulty with everyday tasks and feeling disoriented. "If you find yourself struggling with tasks you have been doing for years, such as cooking or balancing the checkbook, it may be a sign of early cognitive changes," says Dr. Sevil Yasar, a geriatrician at Johns Hopkins. "Additionally, disorientation can be a sign of Alzheimer's. Those with the disease may lose track of time or forget where they are, even in familiar places."
Lisa P. Gwyther, co-author of The Alzheimer's Action Plan: A Family Guide, adds, "Time perception is a real issue with Alzheimer's. Five minutes can feel like five hours, and a loved one may think they haven't seen someone in years, even if it's only been a few days." If you or a loved one is experiencing these symptoms, it may be time to consult a healthcare professional.