FDA extended the review period by three months for the sBLA of once-weekly lecanemab-irmb subcutaneous injection (LEQEMBI IQLIK) as a starting dose for early Alzheimer's disease.
New PDUFA action date is August 24, 2026.
Extension due to additional information submitted, classified as a major amendment.
No FDA concerns raised to date regarding approvability.
Subcutaneous starting dose:
500 mg weekly via autoinjector (2 x 250 mg injections, ~15 seconds each).
Subcutaneous maintenance dosing (360 mg weekly) approved in August 2025.
Announcement made by Eisai and Biogen on May 8, 2026.