BRIEF—US Court lifts decree on Xellia’s Cleveland facility

Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016.

The Modified Decree sets out the processes with which Xellia must comply to conduct manufacturing activities at the Cleveland site. Since entering the Decree, Xellia’s site has been regularly inspected by the US Food and Drug Administration (FDA) to determine compliance with rules and regulations.

In March 2024, Xellia received a VAI (Voluntary Action Indicated) classification, a milestone demonstrating a ‘continued state of compliance’, based on repeated positive feedback from inspections. On the back of this classification, the US Court of Law has vacated the Modified Consent Decree.

Xellia chief executive Michael Kocher commented: “Our team in Cleveland has done an excellent job of navigating the FDA’s inspections over the years, providing prompt and comprehensive responses to observations and information requests. The team’s perseverance has been rewarded with the lifting of the Decree, which is great news for Xellia. Our sincere thanks to everyone at the Cleveland site.”