BioArctic’s partner Eisai has secured approval from the Ministry of Health and Prevention in the United Arab Emirates (UAE) for Leqembi (lecanemab) to treat Alzheimer’s disease (AD).
The Swedish research-based biopharma company stated that Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia, as these were the groups in which treatment was commenced in clinical trials.
Leqembi selectively binds to both soluble amyloid-beta (Aβ) protofibrils and insoluble fibrils, which are key components of Aβ plaques in AD.
The drug is said to be the first approved treatment shown to slow disease progression and reduce cognitive and functional decline.
The approval in the UAE is based on the extensive global Phase 3 Clarity AD study.
In this study, lecanemab achieved its primary endpoint and all major secondary endpoints with statistically significant results.
Leqembi is approved in the US, Japan, China, South Korea, Hong Kong, and Israel. It is currently being marketed in the US, Japan, and China.
The therapy is the result of a long-term collaboration between BioArctic and Eisai. The antibody was initially developed by BioArctic.
Eisai handles the clinical development, market approval applications, and commercialisation of Leqembi for Alzheimer’s disease.
In the UAE, Biogen is responsible for commercialisation. Both companies partnered in 2014 for joint development and commercialisation.
BioArctic retains the rights to commercialise lecanemab in the Nordic region.
Eisai has also applied for approval of the antibody-drug in 11 additional countries and regions, including the European Union (EU).
In March 2024, a supplemental biologics license application (sBLA) for intravenous maintenance dosing was submitted to the US Food and Drug Administration (FDA). It was accepted in June.
Additionally, a rolling biologics BLA for a subcutaneous injection formulation was initiated in the US under the fast track status in May.
In addition to Leqembi, BioArctic has a research portfolio that includes antibodies targeting Parkinson’s disease and ALS, as well as other projects focused on AD. In October last year, Eisai and Biogen announced positive results of Leqembi’s subcutaneous (SC) formulation, comparing results from earlier trials with intravenous infusion administration.
