Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost
Leqembi (lecanemab-irmb), developed by Eisai and Biogen, is approved in multiple countries, including the U.S., Japan, China, South Korea, and others, for early Alzheimer's disease treatment13.
In January 2025, the FDA approved IV maintenance dosing for Leqembi, allowing patients to transition from biweekly to monthly intravenous infusions after the 18-month initiation phase13.
A supplemental Biologics License Application (sBLA) for a subcutaneous, weekly autoinjector form of Leqembi was accepted by the FDA in January 2025, with a decision (PDUFA) date set for August 31, 2025135.
The subcutaneous version aims to simplify treatment, enabling easier administration and reducing the need for hospital visits, which could eventually improve patient access and adherence5.
Eisai and Biogen’s regulatory progress includes applications and reviews ongoing in several markets, while the European Commission is still processing approval after a positive EMA opinion13.
While the FDA has approved the first Alzheimer's blood test, analysts suggest that it will take time before this test meaningfully accelerates Leqembi's market adoption, due to factors like clinical integration, reimbursement, and changes in diagnosis patterns (inferred from analyst expectations; specific details on the analyst's statement not found in the search results).
Sources:
1. https://www.eisai.com/news/2025/news202506.html
3. https://www.eisai.com/news/2025/news202524.html
5. https://www.pharmaceutical-technology.com/news/eisai-and-biogens-subcutaneous-leqembi-set-for-fda-review/