On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer’s disease in patients with mild cognitive impairment or at the mild dementia stage of the disease.
Leqembi® has previously been approved for the same indication in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.
On 10 June 2024, Eisai and Biogen announced that the FDA accepted Eisai’s sBLA for Leqembi® for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.