Alzheimer’s disease (AD) treatment reaches a pivotal milestone as Eisai Co., Ltd. and Biogen Inc. announce the U.S. Food and Drug Administration’s (FDA) acceptance of Eisai’s Supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance dosing of lecanemab-irmb, known as LEQEMBI® in the US. The action date for the Prescription Drug User Fee Act (PDUFA) is scheduled for January 25, 2025. LEQEMBI is designated for treating mild cognitive impairment or mild dementia stage of disease in early AD patients.
The proposed monthly IV maintenance regimen, subsequent to the biweekly IV initiation phase, aims to sustain effective drug concentration for clearing highly toxic protofibrils responsible for ongoing neuronal injury. The sBLA relies on modeling of observed data from Phase 2 study (Study 201), its open-label extension (OLE), and the Clarity Alzheimer’s disease study (Study 301) along with its OLE.
A Promising Advancement in Sustained Alzheimer’s Disease Treatment
AD, a progressive ailment triggered by toxic amyloid proteins, requires sustained treatment as the pathophysiological process persists throughout a patient’s life. LEQEMBI’s continued treatment beyond the 18-month core phase has shown benefits in removing highly toxic protofibrils, leading to prolonged clinical and biomarker benefits. If approved, the once-monthly dosing regimen will offer a less burdensome and more patient-friendly treatment option.
In addition to IV maintenance dosing, Eisai has initiated a rolling submission of a Biologics License Application (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing. LEQEMBI is currently approved in the US, Japan, China, and South Korea, with applications under review in various other countries.
Eisai spearheads lecanemab’s global development and regulatory submissions, with both Eisai and Biogen sharing commercialization and promotion responsibilities. LEQEMBI’s approval would mark a significant advancement in the treatment landscape for early Alzheimer’s disease patients, offering a promising therapeutic option to improve patient outcomes and quality of life.
Safety Considerations and FDA Progress for LEQEMBI® in Alzheimer’s Disease Treatment
It’s essential to consider the safety information associated with LEQEMBI. It carries warnings regarding amyloid-related imaging abnormalities (ARIA), which can include edema and hemosiderin deposition. ARIA incidents vary in incidence and timing, with some potentially serious or life-threatening events. The drug is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or any of its components. Physicians should discuss the risks and benefits of LEQEMBI treatment with patients, considering factors such as genotype and potential ARIA risk.
In conclusion, Eisai and Biogen’s LEQEMBI® IV maintenance dosing application acceptance by the FDA marks a significant step forward in Alzheimer’s treatment. Pending approval, LEQEMBI has the potential to offer a valuable treatment option for early Alzheimer’s disease patients, addressing unmet needs and enhancing patient care in the fight against this debilitating condition.
Resource: Biogen, June 09, 2024
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