The European Medicines Agency's expert committee has decided against approving lecanemab, sold as Leqembi, for people with early Alzheimer's disease. In the committee's view, the benefits of the drug were not large enough to outweigh its risks. The decision came from the Committee for Medicinal Products for Human Use, or CHMP, the body that assesses medicines and makes the first-step recommendation in the EMA's two-stage licensing process.
The practical consequence is straightforward: patients across the EU will not be able to access lecanemab in the near future. That puts Europe out of step with several other regulators, as Alzheimer's Research UK notes the drug has already been approved in the US, Japan, China, Hong Kong, Israel and South Korea.
For families following the arrival of the first treatments that target the underlying biology of Alzheimer's rather than just symptoms, the split verdict is a reminder that regulators are weighing the same clinical trial data and reaching different conclusions about how meaningful the benefit is relative to the risk. Approval in one country says little about what will happen elsewhere.
Attention in the UK now turns to the MHRA, which has yet to announce its own decision on lecanemab. Alzheimer's Research UK says it is tracking how the drug is being scrutinised by regulators worldwide as those judgements come in.