Eisai and Biogen Launch Alzheimer's Drug Leqembi in EU Markets with Controlled Access

What's Happening?

Eisai and Biogen have launched their Alzheimer's drug Leqembi in Austria and Germany, marking its debut in the European Union. The drug, an anti-amyloid antibody known as lecanemab, targets early-stage Alzheimer's disease. The European Commission approved Leqembi in April, following a previous rejection due to concerns over its efficacy and potential side effects. The drug is now available under a controlled access program, which limits its distribution and requires patient monitoring for side effects. This program is designed to ensure safety, particularly for patients with mild cognitive impairment and mild dementia who have one or no copies of the ApoE4 genetic variant, as they are less likely to experience adverse effects like brain swelling and bleeding.

Why It's Important?

The launch of Leqembi in the EU is significant as it provides a new treatment option for Alzheimer's patients, potentially improving their quality of life. The controlled access program aims to mitigate risks associated with amyloid-targeting drugs, addressing safety concerns that have previously hindered approval. This development could influence future regulatory decisions and encourage the introduction of similar treatments. The drug's availability in major EU markets may also boost its global sales, which have been modest despite approval in other regions, including the U.S. The success of Leqembi could pave the way for other innovative Alzheimer's treatments, such as Eli Lilly's Kisunla, which is expected to enter the market soon.

What's Next?

Eisai and Biogen will continue to monitor the rollout of Leqembi in Austria and Germany, ensuring compliance with the controlled access program. The companies are likely to expand the drug's availability to other EU countries, contingent on regulatory approvals and market demand. The success of Leqembi in these initial markets could influence its adoption in additional regions, potentially increasing its global footprint. Stakeholders, including healthcare providers and patients, will be closely watching the drug's performance and safety profile, which could impact future treatment protocols and research in Alzheimer's disease.