Stockholm, October 15, 2025 – The Swedish Competition Authority has closed its investigation into the pricing of the rare disease drug Namuscla, concluding that while treatment costs in Sweden have risen sharply, the evidence does not justify further action.
The authority launched the investigation in May 2024 after a preliminary study suggested possible overpricing of certain orphan medicines—drugs developed for rare conditions and granted exclusivity under the EU Orphan Regulation. Namuscla, used to treat a rare muscle stiffness disorder, benefits from such exclusivity even after its patent protection expired.
The inquiry focused on whether the drug’s pricing could amount to an abuse of dominance through excessive pricing. Although the analysis confirmed a significant increase in per-patient treatment costs since the drug’s introduction, the authority found insufficient grounds to establish a breach of competition rules.
However, the authority noted that it may reopen the case if future market developments or new evidence warrant a reassessment of Namuscla or other orphan drug pricing practices.
Source: https://www.konkurrensverket.se/informationsmaterial/nyhetsarkiv/2025/konkurrensverket-avslutar-utredning-om-sarlakemedel/
