Biogen, Eisai win FDA approval for subcutaneous LEQEMBI initiation dosing in early Alzheimer's disease
- FDA approved a supplemental BLA for once-weekly LEQEMBI IQLIK subcutaneous injection as an initiation dose for adults with early Alzheimer's disease.
- The autoinjector regimen is 500 mg once weekly as two 250 mg injections; the companies plan a U.S. launch in late August 2026.
- Approval was supported by Phase 3 Clarity AD long-term extension data showing subcutaneous exposure equivalent to IV dosing, with expected comparable ARIA-E rates and a generally similar safety profile.
- LEQEMBI IQLIK also can be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment, and patients may switch between IV and subcutaneous administration.