The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
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Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
Kineret is an interleukin-1 receptor antagonist.
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
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.
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
Shortly after an EUA was issued, Genentech announced that tocilizumab (marketed under the brand name Actemra) was in shortage.
The update was based on data from the COV-BARRIER study.
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.
Findings showed that the trial did not meet statistical significance on the primary endpoint.