Norway bans routine use of new Alzheimers drug over limited efficacy and risks

Norway’s medicines regulator has advised against the routine use of a new Alzheimer’s drug, citing “limited efficacy and serious risks” that outweigh any benefits for patients. In a statement issued on 16 June 2026, the Direktoratet for medisinske produkter (DMP) said it would not recommend hospitals adopt Leqembi, the anti-amyloid therapy recently authorised in Europe, because the evidence shows only modest slowing of cognitive decline and a high incidence of side-effects such as brain swelling and bleeding. “I would not have taken the chance myself,” a DMP spokesperson told NRK .

The regulator’s stance aligns with fresh data from the Norwegian press and independent researchers. Aftenposten reported the same day that Leqembi costs roughly NOK 30,000 per patient per year, delivers at best a 27 % reduction in clinical decline over 18 months, and carries a 10–15 % risk of amyloid-related imaging abnormalities that can be life-threatening . Finnish and Austrian colleagues echoed the caution: Helsingin Sanomat noted that among 330 new medicines approved in the EU between 2015 and 2024, only one—Roche’s haemophilia therapy Hemlibra—demonstrated “major therapeutic added value,” underscoring how rarely breakthrough benefits materialise .

Patient-advocacy groups reacted with disappointment but acknowledged the science. “Families were hoping for more time,” said Kari Paulsrud, chair of the Norwegian Alzheimer’s Association. “We now need to focus on better diagnostics and support services while waiting for therapies that truly change the course of the disease.” The DMP’s decision leaves Norwegian hospitals without an official endorsement to prescribe Leqembi, effectively restricting access to clinical-trial participants or private-pay patients.

Across Europe, regulators are tightening scrutiny of Alzheimer’s drugs. The European Medicines Agency is reviewing its conditional approval of Leqembi and is expected to issue updated guidance by September 2026. Until then, clinicians in Norway and beyond will rely on older symptomatic treatments such as donepezil and memantine, while research into anti-tau and neuro-inflammation approaches continues.