製薬

Eisai Seeks Approval for Subcutaneous LEQEMBI in Japan

Eisai and its global partner Biogen have filed a new drug application with Japan's Pharmaceuticals and Medical Devices Agency seeking approval of a subcutaneous version, SC‑AI, of its anti‑amyloid LEQEMBI for the treatment of early Alzheimer's disease. If approved, this version would permit patients to receive injections at home from the outset-a major shift from the existing intravenous regimen. Data from the Phase 3 "Clarity AD" open-label extension supports the application. Weekly subcutaneous dosing of 500 mg, using two 250 mg injections, provides similar levels and results as IV dosing. It has a strong safety profile. Less than 2% of patients have reactions to systemic infusions. If approved, LEQEMBI will change Alzheimer's treatment in Japan. It will be the first anti-amyloid therapy that patients can take at home from the…