ViroGates A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Kineret® (anakinra) for suPAR-guided treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) 6ng/ml. EMA has recommended approval for use of Kineret® in COVID-19 to the European Commission which will issue a final decision. COVID-19 infection can lead to death due to an overreaction of the infected person's inflammatory response, often referred to as a 'cytokine storm`i. Based on previous trial results, suPARnostic® was chosen as the tool to identify patients at risk of progressing to severe respiratory failure to guide anakinra treatment. Anakinra is an anti-inflammatory therapy that targets the cytokines IL-1/, which play a role in COVID-19-induced hyperinflammation. Blocking IL-1/before the hyperinflammatory phase can have an important impact on COVID-19 disease progressionii. The positive opinion is based on results from the SAVE-MORE phase 3 trial which found that early identification of candidate patients with suPAR followed by treatment with anakinra resulted in a 64% relative reduction of patients progressing into severe disease and death, in a 55% relative decrease in mortality, which reached 80% relative decrease in mortality for patients with cytokine storm. Results were published in Nature Medicine on 3 September 2021. The SAVE-MORE study used learning from previous trials and demonstrated the effectiveness of anakinra therapy in patients who had not yet progressed to severe respiratory failure but had a poor prognosis, identified by suPARnostic®.