Overview
- The U.S. Food and Drug Administration approved an at-home starter dose of Eisai/Biogen’s Leqembi on Monday, allowing some patients to begin treatment with subcutaneous injections given by themselves or a caregiver.
- The regulator had previously cleared a 360 mg subcutaneous maintenance dose and based its new decision on evidence showing equivalent drug exposure to the established intravenous regimen instead of separate large outcome trials.
- Company data presented at the Alzheimer’s Association meeting reported that a weekly 500 mg autoinjector produced pharmacokinetic bioequivalence with the biweekly 10 mg/kg IV dose and predicted similar biomarker and clinical effects.
- Safety signals in the early reports were broadly similar across routes with far fewer systemic infusion reactions after subcutaneous injection (under 2%) versus IV infusion (about 26%) and low short-term rates of ARIA‑H in small cohorts.
- Human-factor testing and small patient surveys showed strong preference for the short, at-home autoinjector and feasible self- or caregiver-administration after training, but the evidence is mainly company-led and based on limited samples and short follow-up.