A pharmaceutical drug designed to treat Alzheimer’s disease could soon be authorised for sale in Luxembourg. The drug, Leqembi, developed by US company Biogen in collaboration with Japanese pharmaceutical firm Eisai, has already been approved in the United States.
Leqembi targets a very specific group of patients: those with mild cognitive impairments (MCI) or early-stage Alzheimer’s disease where beta-amyloid plaques are present in the brain. It is not effective for patients in advanced stages of Alzheimer’s or for other forms of dementia without amyloid deposits.
Unlike existing treatments that address symptoms, Leqembi aims to influence the disease’s underlying mechanisms. Clinical trials suggest that an 18-month treatment could delay symptom progression by approximately six months.
However, the drug carries significant risks, including brain bleeding and severe neurological side effects. Administered intravenously every two weeks, Leqembi requires strict patient monitoring throughout the treatment.
The annual cost per patient is estimated at nearly €25,000, according to a statement released by the Dementia Information Centre on Thursday.
The European Medicines Agency (EMA) initially refused to authorise Leqembi but recommended its approval in November 2024, albeit with strict limitations. Final authorisation now depends on the European Commission’s decision.
Luxembourg’s Minister of Health, Martine Deprez, stated in early February that the EMA’s recommendations regarding Leqembi are still being reviewed. She confirmed that national health authorities are in close contact with the EMA to stay informed.
Before Leqembi can be introduced to the Luxembourg market, the Grand Duchy’s social security system and the National Health Fund (CNS) must determine how the drug will be positioned for reimbursement. Once this process is complete, the manufacturer can make the drug available in Luxembourg.
