On 22 August 2024, Eisai and Biogen announced that Leqembi® (lecanemab) has received marketing authorisation from the UK’s MHRA for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease. The UK is the first country in Europe to authorise Leqembi®. As with approvals in other jurisdictions, the approval was primarily based on results of the global Phase III Clarity study.
However, in a draft guidance issued on 22 August 2024, the UK’s National Institute for Health and Care Excellence (NICE) states that the benefits of lecanemab are too small to warrant making the drug available on the NHS.
Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the European Union, Australia, Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.