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10 Nov 2022

Development of suPAR tests for commercial use in the US is a post-authorisation reqirement in new EUA of Kineret for COVID-19

ViroGates announces the emergency use authorisation of Kineret treatment for COVID-19 related pneumonia with a post-authorisation requirement on developing suPAR tests for commercial use in the US

ViroGates announces that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for the use of Sobi®’s medicine Kineret (anakinra) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma suPAR.

The authorisation is based on the results of suPAR-guided Kineret treatment from the SAVE-MORE phase 3 study, published in Nature Medicine on 3 September 2021. In this study, suPAR was used to identify patients at risk of progressing to more severe disease and thus being eligible for treatment. As ViroGates’ suPARnostic® products are not presently commercially available in the US, the authorisation is based on an alternative patient identification method.

However, the FDA has issued a post-authorisation requirement related to the development of suPAR for commercial use in the US. ViroGates has agreed to collaborate with Sobi to identify the appropriate regulatory pathway and associated analytical and clinical requirements with the intention to submit a marketing application no later than 31 January 2025. ViroGates has required funding from Sobi for the regulatory, analytical and clinical work related to the submission with initiation in 2022 to meet the submission deadline. A contractual agreement is still pending.

COVID-19 can progress to severe respiratory failure and death due to an excessive inflammatory response[i]. Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1α and β, which play a role in COVID19-induced hyperinflammation[ii]. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression[iii].

suPAR-guided Kineret treatment was shown to improve outcomes, reduce progression to severe respiratory failure and mortality in patients hospitalised with COVID-19 pneumonia requiring supplemental oxygen, and the benefits were maintained long-term. This illustrates the benefit of measuring suPAR levels to stratify patients for treatment.

Jakob Knudsen, CEO of ViroGates, says: “We congratulate Sobi on the EUA of Kineret for treating COVID-19 in the US. We appreciate the thoroughness of the FDA during the approval process, where ViroGates has been involved several times. We are happy to learn that the FDA considers suPARnostic® to be such an important tool for patient identification to include the commercial development of ViroGates’ suPAR tests in the post-authorisation requirements. We are looking forward to collaborating with Sobi on developing our suPARnostic® products related to COVID-19 for commercial use in the US.”

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