FDA extends review for Alzheimer's drug LEQEMBI IQLIK to August 24, 2026, for subcutaneous use approval.

The FDA has extended the review period by three months to August 24, 2026, for the supplemental Biologics License Application of LEQEMBI IQLIK, a once-weekly subcutaneous injection for early Alzheimer's disease treatment. This extension allows the FDA to review additional information requested as a major amendment, with no current concerns about the drug's approvability. LEQEMBI is already approved in over 50 countries and offers a new administration option following prior approval of intravenous maintenance dosing. Eisai and Biogen continue to engage with the FDA to bring this treatment option to patients, aiming to provide more flexibility in Alzheimer's care.