Potential Use of Leqembi as a Injectable Treatment for Alzheimer's Disease, Study Finds
The Alzheimer's drug Leqembi, proven to slow the disease's progression, could offer a convenient treatment option with two weekly shots at home, according to a study by Eisai A potential breakthrough for patients seeking an easier way to receive treatment
The Alzheimers drug Leqembi, the first medication confirmed to decelerate the progression of the illness, may be administered as a series of two weekly injections at home, according to a study conducted by drug manufacturer Eisai. This could potentially offer patients a more convenient approach to receiving treatment. Presently, the drug is authorized by the US Food and Drug Administration and needs to be given intravenously every two weeks, demanding patients to allocate approximately an hour at an infusion center for each administration.
According to the Alzheimer's Association, 14% of Hispanic people 65 and older have Alzheimer's dementia, compared to 10% of White older adults.
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Older Hispanic people are disproportionately more likely than older White people to develop Alzheimers, research shows
A study presented at the Clinical Trials on Alzheimer's Disease conference in Boston on Wednesday revealed that a set of two weekly injections yielded similar results to twice-monthly IV infusions after a six-month period. The results showed comparable levels of safety, drug concentration in the blood, and efficacy in clearing amyloid plaque buildup in the brain, according to Eisai. Alex Scott, an executive vice president at Eisai, stated that the shot version, administered subcutaneously, would not replace the IV formulation but rather provide patients and doctors with an alternative option.
"Some patients find solace in visiting an infusion center and receiving such a high standard of care," Scott stated.
Eisai announced its intention to submit an FDA approval application for the weekly injectable version of Leqembi by March next year. By then, they expect to possess an extra six months' worth of data on the subcutaneous method of administration.
Dr. Michael Irizarry, Eisai's senior vice president of clinical research in neurology, emphasized the importance of prescribers ensuring that patients or caregivers know how to administer the shots consistently each week and providing appropriate safety monitoring.
Leqembi does not reverse the memory loss and cognitive impairment associated with Alzheimer's disease. In a clinical trial, the drug demonstrated a slowing of disease progression, as measured by cognitive and daily task performance scales, by approximately one-third compared to a placebo after eighteen months of treatment.
Eisai disclosed that the continuation of treatment for two years resulted in sustained benefit. Furthermore, patients who initiated the drug at an earlier stage of the disease reported even greater benefit.
Doses of Leqembi are seen.
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Neurologist: The Alzheimer's drug marks the end of the beginning, not the beginning of the end.
Both Leqembi and another drug, Eli Lilly's donanemab, which is anticipated to receive approval this year, function by eliminating the amyloid plaque accumulations in the brain linked to Alzheimer's disease. Donanemab is infused intravenously once every month.
In the results announced on Wednesday, Eisai and its partner Biogen reported that the weekly injection form of Leqembi demonstrated a 14% greater reduction in plaques compared to the intravenous form after six months of treatment. According to the companies' press release, approximately 15% of patients experienced mild to moderate injection site reactions such as redness, irritation, or swelling.
To administer the subcutaneous form, two shots are given each week using an autoinjector. Eisai's Irizarry explained to CNN that this approach is necessary due to the larger volume of drug required, which cannot be effectively administered in a single device.
ARIA, which stands for amyloid-related imaging abnormalities, is a significant safety concern associated with drugs in this category. It is detected through brain imaging and is characterized by the removal of amyloid plaques, which can result in edema and hemorrhage. These adverse effects, known as ARIA-E and ARIA-H, respectively, can be severe and occasionally fatal.
According to presentation slides from Eisai, the rates of ARIA were comparable between patients receiving Leqembi as weekly shots and those receiving it through IV infusion. In fact, the occurrence of ARIA-E, or brain swelling, was slightly higher in the group receiving weekly shots (approximately 17%) compared to the IV group (13%). Similarly, the occurrence of ARIA-H, or brain bleeding, was higher in the shot group (22%) compared to the IV group (17%).
The results on the weekly shots are from about 70 patients, compared with more than 700 who got the drug via IV.
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According to a study, regular internet usage in older adults may be associated with a reduced risk of dementia. Despite being the first drug proven to slow the progression of Alzheimer's disease, Leqembi has not been extensively utilized since it received conditional approval from the FDA in January, nor has it obtained full approval in July.
Prescription data from RBC Capital Markets indicates that approximately 500 patients might have received treatment with the drug in September. However, the firm acknowledges that this number may not represent all patients with prescriptions. It is important to note that there are over 6 million individuals estimated to have Alzheimer's disease in the US, with approximately one million in the early stages who could potentially be eligible for the drug.
Scott from Eisai declined to disclose the exact number of patients currently taking Leqembi, citing the company's quiet period before reporting financial results next month. Nevertheless, he mentioned that Eisai had projected 10,000 patients to be on Leqembi by March 2024 and expressed confidence in this figure, stating, "we are very comfortable with that number."
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According to a research note by RBC analyst Brian Abrahams, although CMS has lifted certain limitations on payment for testing linked to the use of Leqembi, patients may still encounter some out-of-pocket expenses. It is worth noting that the implementation of these changes is currently in progress within the system.
Scott mentioned that the price of the subcutaneous version may vary, but he chose not to give any additional information. He pointed out that since the medicine would be administered at home instead of infusion centers, it would fall under Medicare Part D rather than Medicare Part B. This change could potentially result in reduced out-of-pocket expenses for seniors. However, Scott stated that the specific details are still unclear and may differ among patients.
"We have noticed a great deal of enthusiasm within the industry," Scott shared. "Everyone is currently focused on understanding the most effective ways to treat patients and whether they will receive appropriate reimbursement for such treatments."
