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news.Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics licence application (sBLA) submitted by the former for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector (SC-AI) as a starting dose for early Alzheimer’s disease.
Alzheimer’s disease is characterised by amyloid beta and tau pathologies, driven by ongoing neurotoxicity from protofibrils. Credit: StanislavSukhin / Shutterstock.com.
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The submission relates to patients with mild cognitive impairment or mild dementia due to Alzheimer’s.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 24 May 2026. If approved, the Leqembi Iqlik 500mg SC dosing regimen, delivered as two 250mg injections weekly, would offer an alternative to current bi-weekly intravenous (IV) administration.
This would provide care partners and patients the option of at-home subcutaneous treatment initiation and maintenance therapy (360mg), offering flexibility between intravenous (IV) and SC routes throughout treatment.
The sBLA is supported by results from various dosing studies, including the Phase III Clarity AD open-label extension sub-studies after an 18-month core study in early AD individuals.
Results indicated that once-weekly 500mg SC-AI achieved exposure equivalent to bi-weekly IV dosing, with similar clinical and biomarker benefits. Safety profiles were also comparable, with less than 2% incidence of infusion reactions or systemic injection.
AD is characterised by amyloid beta (Aβ) and tau pathologies, driven by ongoing neurotoxicity from protofibrils.
Leqembi currently holds approval in 53 countries and regions and is under regulatory review in seven more.
In August 2025, the FDA approved Leqembi Iqlik 360mg for weekly subcutaneous maintenance following bi-weekly intravenous treatment for 18 months.
Eisai leads global development and submissions for lecanemab, with both companies sharing commercial responsibilities.
In November 2025, Eisai and Biogen announced the UK Medicines and Healthcare products Regulatory Agency’s approval for Leqembi for IV maintenance dosing once every four weeks to treat early Alzheimer’s.
