BioArctic AB’s partner Eisai publicized that the U.S. Food and Drug Administration (FDA) had accepted Eisai’s Supplemental Biologics License Application (sBLA) for less frequent monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV) maintenance dosing.
This news holds significance in the treatment of Alzheimer’s disease (AD) in patients. The Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025, and once approved, Leqembi may offer sustained treatment that’s less burdensome and easier for patients and care partners to continue long-term.
What’s Happening & Why This Matters
In layman’s terms, Alzheimer’s disease is a progressive disease caused by toxic amyloid proteins. As such, prolonged treatment is necessary. The new IV maintenance regimen, if approved, will ensure the continued removal of highly toxic protofibrils. The less frequent monthly IV dosing maintains an effective drug concentration, which sustains the clearance of highly toxic amyloid beta (Aβ) protofibrils. Applications for review in several other countries have been made, with the rolling submission of a BLA for the Leqembi subcutaneous autoinjector for weekly maintenance dosing now being reviewed by the FDA as well.
Lecanemab (Leqembi®) is poised for approval in various countries, including the U.S., Japan, China, and South Korea, making it widely available to Alzheimer’s disease patients. Moreover, Eisai has taken responsibility for the clinical development, applications for market approval, and commercialization of Lecanemab for Alzheimer’s disease.
TF Summary: What’s Next
In short, the Leqembi’s future looks promising as it awaits the decision of the FDA on the sBLA for less frequent monthly lecanemab-irmb IV maintenance dosing. Once approved, this could transform treatment for those suffering from Alzheimer’s disease.