Kuiken schreef op 2 februari 2023 16:59:
Alzheimer News Today:
Lecanemab Granted Priority Review by Regulators in Japan
Alzheimer's therapy just won accelerated approval in US as Leqembi
by Steve Bryson, PhD | January 31, 2023
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 in the country for new medicines for serious medical conditions.
Earlier this month, the therapy was granted accelerated approval in the U.S. under the brand name Leqembi to treat Alzheimer’s patients with mild cognitive impairment or mild dementia.
At the same time, Eisai also submitted an application to U.S. regulators asking for the therapy’s approval under a traditional pathway. Similar approval applications are now being reviewed in Europe and China, according to a Biogen press release.