On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for early Alzheimer’s disease.
In late January 2025, the European Commission had asked the CHMP to re-consider the positive opinion granted for Leqembi® in November 2024 following safety information that had since become available.
The CHMP’s reaffirmed recommendation for approval means that the EC will now resume its decision-making process for lecanemab’s marketing authorisation.
The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease. However, in the same month, the UK’s NICE determined that the benefits of lecanemab were too small to warrant making the drug available on the NHS. Similarly, earlier in February 2025, the Scottish Medicines Consortium (SMC) declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.