Eisai and Biogen Launch Leqembi in Austria and Germany for Alzheimer's Treatment

Eisai and Biogen have launched Leqembi, a treatment for Alzheimer's disease, in Austria and Germany. The drug received EU approval in April and is indicated for mild cognitive impairment and mild dementia due to Alzheimer's disease. Leqembi targets an underlying cause of Alzheimer's and is a first-in-class therapy. Eisai and Biogen have collaborated with healthcare authorities to implement authorization requirements ahead of launch.

Eisai Co., Ltd. and Biogen Inc. have announced the launch of Leqembi in Austria and Germany, marking a significant milestone in the treatment of early Alzheimer's disease. The drug, an anti-amyloid beta monoclonal antibody, received European Commission (EC) approval in April 2025 and is indicated for mild cognitive impairment and mild dementia due to Alzheimer's disease. This launch follows a collaborative effort with healthcare authorities to implement authorization requirements ahead of the rollout.

Leqembi is the first therapy to target an underlying cause of Alzheimer's disease, specifically targeting amyloid beta plaque and protofibrils. In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline by 31% at 18 months compared to placebo [1]. The drug is indicated for adult patients with mild cognitive impairment or mild dementia due to Alzheimer's disease who are non-carriers or heterozygotes of the ApoE ε4 gene.

The launch in Austria and Germany follows a controlled access program to ensure patient safety and appropriate use. Common adverse reactions include infusion-related reactions, ARIA-H, headache, and ARIA-E. Eisai and Biogen will co-promote the medication, with Eisai serving as the marketing authorization holder in the EU.

The approval of Leqembi underscores the growing need for innovative therapies in Alzheimer's disease treatment. The drug's potential to slow the progression of the disease offers hope for patients and their caregivers. However, the requirement for a controlled access program may pose challenges in broader patient access.

References:
[1] https://www.quiverquant.com/news/Eisai+and+Biogen+Launch+LEQEMBI%C2%AE+in+Austria+and+Germany+as+First+Alzheimer%E2%80%99s+Disease+Therapy+Approved+in+Europe+Targeting+Amyloid+Beta