Eisai and Biogen have announced that Leqembi® (lecanemab) has been approved for the treatment of Alzheimer’s disease in the United Arab Emirates. The approval is based on results from the global Phase III Clarity study and will allow treatment of patients with mild cognitive impairment (MCI) or at the mild dementia stage of the disease with Leqembi® (aligning with the patient population targeted in clinical trials).
Leqembi® has previously been approved for the same indication in the US, Japan, China, South Korea, Hong Kong and Israel, and applications are under review in the European Union, Australia, Brazil, Canada, Great Britain, India, Russia, 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.