European Commission grants authorisation for Eisai and Biogen therapy

The European Commission has granted marketing authorisation for Leqembi (lecanemab), making it the first therapy in the EU to slow the progression of early Alzheimer’s disease.

Lecanemab is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.

The approval is based on phase 3 data from the Clarity AD trial, which demonstrated that lecanemab slowed disease progression compared with placebo over 18 months.

Gary Hendler, regional chairman and CEO at Eisai EMEA, said: “Today’s decision makes lecanemab the first treatment option in the European Union that can slow the progression of early Alzheimer’s disease and is a key step to making the medicine available to eligible patients.”

The decision applies to all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Eisai will work with reimbursement authorities to ensure timely access.

The drug targets amyloid-beta protofibrils, a toxic form of amyloid that accumulates in the brain and contributes to cognitive decline.

Nick Burgin, president and COO at Eisai EMEA, added: “Achieving optimal outcomes for people treated with the medicine is of paramount importance.”

Biogen’s president for Europe, Wolfram Schmidt, called the approval a milestone in tackling Alzheimer’s.

The most common adverse events observed in the Clarity AD trial included infusion-related reactions, amyloid-related imaging abnormalities, headaches and cerebral oedema.

Eisai leads global development and regulatory submissions for lecanemab, co-commercialising with Biogen. The company aims to ensure appropriate use of the drug in each country where it is introduced.