The US Food and Drug Administration (FDA) has granted approval for a subcutaneous formulation of Leqembi (lecanemab) to be used for initiating treatment in patients with early Alzheimer’s disease, marking a significant step in making the therapy more accessible. The new injectable version can be administered in under one minute, compared with the current intravenous infusion which takes approximately one hour.
Leqembi, developed by Eisai and Biogen, is a monoclonal antibody that targets amyloid-beta plaques in the brain. The FDA’s decision is based on data showing that subcutaneous administration achieves similar blood concentrations and efficacy to the intravenous route, with a comparable safety profile. The approval covers initiation of treatment, with patients potentially transitioning to a maintenance regimen thereafter.
For UK patients and investors, the development carries dual significance. The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are currently assessing Leqembi for use in England and Wales. A NICE draft decision from earlier this year did not recommend the drug on cost-effectiveness grounds, but a final appraisal is awaited. The availability of a cheaper-to-administer subcutaneous version could alter the cost-benefit analysis.
Shares in Eisai rose 3.2% in Tokyo trading following the announcement, while Biogen’s stock gained 1.8% in pre-market US trading. The FTSE 100, meanwhile, slipped 0.3% to 7,812 points on Wednesday, with healthcare stocks mixed. Hikma Pharmaceuticals, which has a focus on injectable generics, edged up 0.5% on hopes of broader market interest in subcutaneous delivery technologies.
Analysts at Shore Capital noted that the approval “removes a key barrier to patient access” and could accelerate global adoption, though they cautioned that UK pricing and reimbursement negotiations remain unresolved. “The convenience factor is substantial, but NICE’s primary concern has been the high cost relative to clinical benefit,” they said in a note.
For UK pension holders and investors with exposure to global healthcare funds, the approval reinforces the long-term commercial potential of Alzheimer’s therapies, a market projected to exceed £10 billion annually by 2030. However, any direct impact on UK-listed stocks remains limited, as neither Eisai nor Biogen is listed on the London Stock Exchange.