By Fineline Cube 
Japan-based Eisai (TYO: 4523) and US-based Biogen (NASDAQ: BIIB) have officially launched Lecanemab (LEQEMBI)—the first anti‑amyloid β monoclonal antibody approved by the European Commission (EC) for a cause‑based treatment of Alzheimer’s disease (AD). The drug entered the Austrian market on 25 August, 2025 and will hit German pharmacies on 1 September, 2025.
Why Lecanemab Is a Milestone
| Feature | Details |
|---|---|
| Mechanism | Targets soluble amyloid‑β (Aβ) aggregates, slowing neurodegeneration |
| Indication | Adults with mild cognitive impairment (MCI) or mild dementia early AD; requires ApoE ε4 non‑carrier or heterozygote status and confirmed amyloid pathology |
| Regulatory status | EC approval (April 2025); first therapy to target underlying AD pathology in the EU |
| Launch framework | Controlled Access Program (CAP) in Austria & Germany to ensure rapid, safe patient enrollment |
Commercial Arrangement
- Lead developer & regulator – Eisai spearheads global submissions and holds Marketing Authorization Holder status in the EU (excluding the Nordic countries).
- Co‑promotion – Eisai and Biogen jointly promote the product in the EU, with Eisai ultimately making the final business decisions.
- Distribution – Eisai will distribute Lecanemab across the EU, leveraging its established supply chain.
Key Takeaways for Investors
- Early‑AD market entry – Lecanemab addresses a growing unmet need for disease‑modifying therapy in early AD.
- Strong regulatory footing – EC approval and the Controlled Access Program reduce market‑entry risk.
- Strategic partnership – The Eisai‑Biogen alliance combines manufacturing expertise with a global commercial footprint, positioning the drug for rapid uptake in the EU.-Fineline Info & Tech