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Kineret (anakinra) receives positive opinion from the CHMP for treatment of patients with COVID-19 pneumonia.

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Published:17th Dec 2021
Swedish Orphan Biovitrum AB (publ) (Sobi) announces 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 the 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) 6 ng/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'. The positive opinion is based on results from the SAVE-MORE phase III study 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 (previously reported).

Condition: Coronavirus/Pneumonia
Type: drug

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