The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
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The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
The sBLA is supported by data from 4 randomized, controlled studies that evaluated tocilizumab for the treatment of COVID-19 in more than 5500 hospitalized patients.
Kineret is an interleukin-1 receptor antagonist.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.