Lecanemab has been approved in 48 countries, with ongoing reviews in others, including recent approvals for additional dosing methods in the US, such as intravenous and subcutaneous autoinjectors.

Eisai and Biogen have launched LEQEMBI® (lecanemab), an anti-amyloid beta monoclonal antibody, in Austria and Germany, marking the first EU countries to approve this innovative Alzheimer's treatment.

The drug has demonstrated a 31% reduction in clinical decline over 18 months in clinical trials, showing promise in slowing disease progression.

While effective, lecanemab's common adverse reactions include infusion-related reactions, headache, and ARIA, with serious ARIA-E cases occurring in about 2% of participants.

This launch represents a major step toward increasing access to advanced treatments for early Alzheimer's in Europe, addressing a significant unmet medical need.

Eisai leads global development and regulatory efforts for lecanemab, with both Eisai and Biogen co-promoting the drug in the EU, where Eisai is the Marketing Authorization Holder.

Eisai and BioArctic have a longstanding collaboration, with Eisai responsible for development and commercialization, and BioArctic holding rights to the Nordic region.

The launch involved collaboration with healthcare authorities and the implementation of controlled access programs in Austria and Germany to ensure safe and appropriate use, especially considering safety concerns like ARIA.

Further studies are underway, including trials in preclinical Alzheimer's and for patients with inherited forms, exploring early intervention and broader applications of lecanemab.

The EU launch underscores the importance of early intervention in Alzheimer's, supported by clinical trial results, safety considerations, and regulatory pathways.

Eisai and BioArctic's long-term collaboration has been instrumental, with the drug representing a significant advancement in addressing unmet needs in Alzheimer's disease.