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Revolutionizing Alzheimer's Treatment: Study Proposes Leqembi Administration Through Shots Instead of IV Infusion

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"Innovative Approach: Leqembi, Alzheimer's Breakthrough Drug, May Shift to Weekly Shots According to Eisai Study"

A groundbreaking study from drugmaker Eisai suggests that Leqembi, the first drug proven to slow Alzheimer's progression, could potentially be administered as a set of two weekly shots at home. Currently, the drug, which received full approval from the US Food and Drug Administration in July, is delivered through intravenous infusion every two weeks, requiring patients to spend about an hour at an infusion center. The proposed shift to weekly shots aims to offer a more convenient treatment option for patients.

Presented at the Clinical Trials on Alzheimer's Disease conference in Boston, the study revealed that a set of two shots per week produced comparable results to twice-monthly IV infusions after six months. The evaluation considered factors such as safety, drug concentration in the blood, and the drug's ability to clear amyloid plaque buildups in the brain.

Alex Scott, an executive vice president at Eisai, emphasized the potential benefits of the shot version, which would be administered subcutaneously, providing an alternative choice for patients and doctors. Scott noted that the new option wouldn't replace the IV formulation but would instead broaden treatment choices, acknowledging that some patients prefer the care received at infusion centers.

Eisai plans to submit an application for FDA approval of the weekly shot form of Leqembi by the end of March next year, accompanied by additional data on the subcutaneous administration's efficacy. The flexibility of administration—allowing either self-administration by the patient or assistance from a caregiver—opens up possibilities for enhanced patient autonomy.

Dr. Michael Irizarry, Eisai's senior vice president of clinical research in neurology, highlighted the importance of prescribers ensuring proper training for patients or caregivers handling the new administration method consistently each week. While Leqembi doesn't reverse memory loss associated with Alzheimer's, it demonstrated a significant slowing of the disease's progression in clinical trials, offering a promising avenue for more manageable treatment options.

"Extended Benefits: Leqembi's Alzheimer's Progression Slowdown Sustained in Two-Year Study"

Further insights into the effectiveness of Leqembi in slowing Alzheimer's progression were revealed in additional data presented on Wednesday. The study demonstrated sustained benefits over a two-year period, indicating the drug's continued impact on the course of the disease. Notably, patients experienced greater benefits when initiating treatment earlier in the disease's progression, showcasing the potential for early intervention.

Both Leqembi and Eli Lilly's donanemab, expected to receive approval this year, share a mechanism of action—clearing amyloid plaque buildups associated with Alzheimer's disease. While donanemab is administered via IV infusion once a month, Leqembi's proposed weekly shot form exhibited promising results. The subcutaneous administration, delivered through two shots weekly via an autoinjector, proved to be effective in reducing plaques by approximately 14% more than the IV form after six months of treatment.

However, safety considerations include injection site reactions, with around 15% of patients experiencing mild to moderate reactions such as redness, irritation, or swelling. The subcutaneous form's administration requires two shots due to the volume of drug needed.

The main safety concern for drugs in this class involves amyloid-related imaging abnormalities (ARIA), detectable through brain imaging. ARIA can manifest as edema (ARIA-E) and hemorrhage (ARIA-H), potentially leading to severe outcomes. The rates of ARIA were comparable for patients receiving Leqembi as weekly shots and via IV infusion, with slightly higher rates in the weekly shot group. Dr. Georges Naasan, an associate professor of neurology, expressed concerns about the potentially increased rate of ARIA, emphasizing the need for thorough counseling regarding the associated risks.

While the results on the weekly shots are based on a smaller cohort of about 70 patients compared to over 700 in the IV group, the findings contribute valuable insights into the drug's safety profile and efficacy. As the landscape of Alzheimer's treatment evolves, these developments underscore the ongoing commitment to finding more accessible and effective solutions for patients facing this challenging disease.

"Leqembi's Potential and Hurdles: Breaking Ground in Alzheimer's Treatment Faces Limited Usage and Cost Concerns"

Despite its groundbreaking status as the first drug proven to slow the progression of Alzheimer's disease, Leqembi has encountered limited usage since receiving conditional approval from the FDA in January and fuller approval in July. Prescription data indicates that approximately 500 patients may have been treated with the drug in September, according to financial research firm RBC Capital Markets. However, this figure may not represent all patients with prescriptions.

Considering that there are more than 6 million people estimated to have Alzheimer's in the US, with perhaps a million in the early stages eligible for the drug, the relatively low usage raises questions about accessibility and adoption. Eisai's forecast anticipates 10,000 patients taking Leqembi by the end of March 2024, reflecting confidence in the drug's potential impact.

Leqembi comes with a price tag of about $26,500 per year before insurance, with coverage expanding following full FDA approval and support from the Centers for Medicare and Medicaid Services (CMS). However, patients still face some out-of-pocket costs, and changes in payment restrictions for associated testing are in progress. The subcutaneous version's pricing may differ, but details remain undisclosed. Eisai's Alex Scott mentioned that the subcutaneous administration at home could fall under Medicare Part D, potentially reducing out-of-pocket costs for seniors, although the specifics are yet to be clarified.

Amid the optimism surrounding Leqembi's potential, the challenges lie in navigating reimbursement structures and ensuring adequate coverage for patients. The evolving landscape of Alzheimer's treatment demands a balance between innovation, accessibility, and financial feasibility to maximize the drug's impact on those affected by this challenging disease.

In conclusion, Leqembi's groundbreaking role as the first drug proven to slow the progression of Alzheimer's disease brings hope for improved treatment. Despite its potential, the drug faces challenges in terms of limited usage since receiving FDA approval and concerns about costs and reimbursement structures. With approximately 500 patients treated in September, a fraction of those who could potentially benefit from the drug, questions about accessibility and adoption come to the forefront.

Eisai's optimistic forecast aims for 10,000 patients on Leqembi by March 2024, showcasing confidence in the drug's impact. However, addressing out-of-pocket costs, reimbursement intricacies, and expanding access to a broader patient population remain critical hurdles. The evolving landscape of Alzheimer's treatment requires a delicate balance between innovation and ensuring that these groundbreaking therapies are accessible and financially viable for those in need. As Leqembi continues to shape the future of Alzheimer's treatment, the focus on overcoming these challenges will be essential for maximizing its positive impact on patients and their families.

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