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Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

Concept of a human head with a puzzle in the middle.
Leqembi is the first therapy that targets an underlying cause of AD to be authorized in the EU (Shutterstock)
Key Takeaways
  • Leqembi, Eisai and Biogen’s treatment for early Alzheimer’s disease, was approved for marketing across the EU on 15 April.
  • Eisai said it would work collaboratively with national authorities to secure reimbursement for the drug.
  • It plans to launch Leqembi in Germany and Austria in fiscal year 2025 and will stagger the drug’s launch in other EU countries over the next few years.
  • A controlled access program (CAP) and post-approval safety study (PASS) registry will need to be approved and implemented in these EU member states ahead of launch, aligning with the European Commission's approval requirements.

Eisai plans to launch Leqembi (lecanemab) in Germany and Austria in fiscal year 2025 and will stagger the drug’s launch in other EU countries over the next few years, following...

Leqembi, which Eisai co-commercializes with Biogen and is already approved for marketing in the US and other countries, became the first amyloid-targeting drug for AD to be authorized in the...

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