Swedish regulators influence Alzheimer drug dosing and anesthesia equipment use

BioArctic is seeking approval from the European Medicines Agency to shift the maintenance dosing of its Alzheimer’s drug Leqembi (lecanemab) from bi‑weekly to monthly after an initial 18‑month period. The company says the change could cut treatment visits and improve cost‑effectiveness, prompting a new dialogue with Sweden’s NT‑council on health‑economic assessments.

Separately, Sweden’s Health and Social Care Inspection (Ivo) has prohibited the reuse of a multi‑patient anesthesia infusion set introduced by the Västra Götaland Region at Alingsås and Angered hospitals. Ivo argues the practice does not meet EU regulations for in‑house medical device production, despite claims of reduced material use and climate impact, and has set a July 23 deadline before fines of up to SEK 300,000 may be imposed.