EISAI CO

Eisai and Biogen receive positive CHMP opinion for lecanemab, an Aß monoclonal antibody, as a treatment for early Alzheimer's disease in ApoE e4 non-carriers or heterozygotes with confirmed amyloid pathology. The European Commission is expected to make a final decision on the marketing authorization within 67 days.

Europe's EMA partially approves Leqembi for mild Alzheimer's, limited to patients with one or no ApoE4 gene copy, due to lower risk of brain bleeding.

Lecanemab use in the U.S. and Japan shows ARIA rates similar to trials despite broader patient populations. Japan's ARIA rates are half of the U.S., mirroring Phase 3 trial results. Lecanemab is approved in several countries but rejected by the EMA and Australia. The U.K. restricts use to non-APOE4 homozygotes, and the NHS does not cover costs. Other countries may follow the U.K.'s example. Lecanemab use is growing in Japan but faces hurdles like limited infusion sites and physician numbers.

NICE declined to recommend lecanemab and donanemab, new monoclonal antibody treatments for Alzheimer’s disease, in draft guidelines due to high costs and concerning side effects, despite MHRA licensing them for early-stage AD patients with no or one copy of the ApoE4 gene.

Eisai and Biogen receive positive CHMP opinion for lecanemab, an Aβ monoclonal antibody for early Alzheimer's disease, with the European Commission expected to make a final decision on its marketing authorization within 67 days.

The EMA’s CHMP now recommends Leqembi for Alzheimer’s patients with mild cognitive impairment or mild dementia, provided they carry one or no copies of the ApoE4 gene variant, due to lower ARIA risk. The EMA is expected to decide on Leqembi’s marketing authorisation in January 2025.

BioArctic announces EMA's CHMP positive recommendation for Eisai's MAA for lecanemab as Alzheimer's treatment, applicable to early Alzheimer's patients who are ApoE ε4 heterozygotes or non-carriers. A European Commission decision is expected within 67 days, following Eisai's request for re-examination of the earlier negative recommendation.

EU drugs regulator recommends approval of Leqembi, an Alzheimer's drug by Eisai and Biogen, for patients with one or no ApoE4 gene variant. If accepted by the European Commission, it could become the first approved Alzheimer's treatment in the EU, with member states deciding on pricing and reimbursement.