BioArctic and Eisai have announced new positive Phase III data on the subcutaneous formulation for Leqembi (lecanemab-irmb). 

The companies presented the data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, US, between 24 and 27 October. 

The Phase III trial (NCT03887455) is an open-label extension (OLE) substudy of the Clarity AD trial which compared the subcutaneous (SC) administration of Leqembi with intravenous infusion (IV). Data revealed that weekly SC administration of the drug resulted in a 14% greater reduction of amyloid plaques as measured by positron emission tomography (PET) at six months compared to biweekly IV administration.  

Incidence of amyloid-related imaging abnormalities (ARIA) with SC administration was found to be similar to IV, indicating that the SC formulation does not lead to an increased risk of ARIA. 

Leqembi is a monoclonal antibody that targets and reduces insoluble amyloid-beta (Aβ) forms in the brain. It is the first and only approved treatment that has demonstrated a reduction in the rate of disease progression in patients with Alzheimer’s.  

Leqembi was awarded full traditional approval in the US in July 2023, as well as in Japan in September 2023. 

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By GlobalData

GlobalData’s consensus forecast projects global sales for Leqembi to exceed $54bn by 2029. 

Leqembi faces competition from Eli Lilly’s donanemab, a similar monoclonal antibody targeting amyloid beta plaques, with GlobalData predicting sales exceeding $5.8bn in 2029. However, the FDA rejected Eli Lilly’s bid for accelerated approval of donanemab in January 2023, leaving Leqembi as the leading drug in this space.

GlobalData is the parent company of Clinical Trials Arena.