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.
Findings showed that the trial did not meet statistical significance on the primary endpoint.
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.
The update was based on data from the COV-BARRIER study.
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
The EUA was issued based on 4 randomized controlled clinical trials that evaluated the efficacy and safety of Actemra in more than 5500 hospitalized patients with COVID-19.
Shortly after an EUA was issued, Genentech announced that tocilizumab (marketed under the brand name Actemra) was in shortage.
Kineret is an interleukin-1 receptor antagonist.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.