Lecanemab Granted Priority Review by Regulators in Japan

Lecanemab (BAN2401), an amyloid-targeted antibody therapy for early Alzheimer’s disease, has been granted priority review in Japan, according to Eisai and Biogen, its developers. Priority review, as designated by the Japanese Ministry of Health, Labour and Welfare (MHLW), shortens the review period of applications seeking approval…

FDA Rejects Accelerated Approval Application For Donanemab

The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s application for the accelerated approval of its amyloid-clearing antibody donanemab for treating Alzheimer’s disease. An accelerated approval lets the FDA grant conditional marketing authorization for a treatment based on preliminary safety and efficacy data, but additional clinical…

Leqembi for Alzheimer’s Patients in US Available Through Soleo Health

Soleo Health was selected by Eisai as the sole specialty pharmacy to carry Leqembi (lecanemab) for Alzheimer’s disease patients prescribed the treatment. Leqembi, approved for use in the U.S. earlier this month, is an anti-amyloid targeted antibody, used to treat mild cognitive impairment or mild dementia due to Alzheimer’s.