Biogen and Eisai Report MHLW Approval of Leqembi Pen (SC) for Early Alzheimer’s Disease

Shots: The MHLW has approved Leqembi Pen (SC autoinjector) administered as 500mg given QW as two pens, each delivered in ~15secs, for the treatment of early Alzheimer's disease Approval was supported by 18mos. P-III Clarity AD data in pts with mild cognitive impairment (MCI) due to AD or mild AD dementia & multiple SC administration…

ByRidhi Rastogi3 days ago

Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

Shots: The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…

ByRidhi RastogiSeptember 3, 2026

Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease

Shots: The US FDA has approved an sBLA for Leqembi Iqlik (lecanemab‑irmb, SC) as an initiation dose administered as 500mg given QW as two 250mg injections, each delivered in ~15secs for the treatment of early Alzheimer's disease Approval was supported by clinical data across multiple studies, with Clarity AD LTE sub-studies showing QW SC Leqembi…

ByRidhi RastogiJuly 14, 2026

Biogen and Eisai Report MHLW Approval of Leqembi Pen (SC) for Early Alzheimer’s Disease

Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease

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