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11-11-2022 | COVID-19 | News

approvalsWatch

FDA authorizes anakinra for severe COVID-19

Author: Claire Barnard

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medwireNews: The US FDA has issued an Emergency Use Authorization permitting use of the interleukin (IL)-1 receptor antagonist anakinra to treat certain hospitalized patients with severe COVID-19.

Currently approved for rheumatoid arthritis, cryopyrin-associated periodic syndromes, and IL-1 receptor antagonist deficiency, anakinra may now be given to hospitalized adults with COVID-19 pneumonia requiring supplemental oxygen who are at risk for progression to severe respiratory failure and are likely to have elevated plasma soluble urokinase plasminogen activator receptor (suPAR) levels.

The FDA says that the decision is “[b]ased on the totality of scientific evidence,” including data from the SAVE-MORE trial, which demonstrated that suPAR-guided anakinra use could reduce the risk for poor outcomes in this patient population.

This announcement follows European authorization of anakinra for certain patients with COVID-19 pneumonia at the end of 2021.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

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