- EU approval follows 5-month reconsideration process after initial July 2023 rejection
- Targets early Alzheimer's patients with 27% slower cognitive decline in trials
- Brain swelling/bleeding risks affect 13% of users in clinical studies
- First amyloid-targeted therapy approved in EU, while competitor Kisunla remains blocked
In a landmark decision reshaping Europe's Alzheimer's treatment landscape, regulators have granted full marketing authorization to Leqembi (lecanemab). This reversal comes after Eisai successfully demonstrated the drug's risk-benefit profile through supplemental data from Phase III trials involving 1,795 participants across 14 member states.
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) recently established reimbursement guidelines requiring quarterly MRI monitoring, creating a blueprint for other EU nations. This conditional approval reflects our evolving understanding of amyloid therapies,stated Dr. Helena Brandt, Munich-based neurologist and European Alzheimer's Consortium member.
Three critical industry shifts emerge from this decision:
- Regulators now demand real-world evidence collection for 5 years post-approval
- Specialized infusion centers must expand 40% to meet projected demand
- Diagnostic imaging referrals expected to increase 300% in Q1 2025
The approval intensifies pressure on European healthcare systems, with France estimating €2.3 billion annual treatment costs. However, analysts project €18 billion in long-term care savings if disease progression delays hold in real-world use.
While Eisai/Biogen celebrates this milestone, Eli Lilly faces ongoing hurdles with Kisunla. The CHMP's maintained rejection underscores Europe's cautious stance on anti-amyloid therapies with similar efficacy but divergent safety profiles.