Emergency Use Authorization

Authorized Use

The FDA has issued an EUA for the emergency use of KINERET 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 high-flow oxygen) who are at risk of progressing to severe respiratory failure, and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). However, KINERET is not approved for this use.

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.

See full Fact Sheet for Healthcare Providers for the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19.

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