Emergency Use Authorization

Authorized Use

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make KINERET® (anakinra) available during the COVID-19 pandemic.

Anakinra has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of COVID-19 in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or highflow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated suPAR.

The emergency use of Kineret is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Read this Fact Sheet for information about KINERET and talk to your healthcare provider about your options or if you have any questions. It is your choice for you to take KINERET or stop it at any time.

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