The recommendation applies to the treatment of early Alzheimer’s disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. 

The CHMP recommendation for the European Commission to approve lecanemab follows Eisai’s request for a re-examination of the CHMP’s earlier negative recommendation. A decision from the European Commission is expected within 67 days.

The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer’s disease, in adult patients who are heterozygotes (carry one copy) or are non-carriers of the Apolipoprotein E ε4 (ApoE ε4) gene.

We now look forward to the European Commission’s decision that is the next step towards providing access to this new treatment for patients in Europe with Alzheimer’s disease.

“We are very happy and grateful that the CHMP, during their re-examination of lecanemab, has recognized that for the patients in this population, the benefit of the treatment is greater than the risk. We now look forward to the European Commission’s decision that is the next step towards providing access to this new treatment for patients in Europe with Alzheimer’s disease,” says Gunilla Osswald, CEO at BioArctic.

Lecanemab is already approved in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and the Great Britain.

Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer’s disease. BioArctic has the rights to commercialize lecanemab in the Nordic region. Currently, BioArctic and Eisai are preparing for joint commercialization in these countries, pending approval from the European Commission.