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.
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.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
Kineret is an interleukin-1 receptor antagonist.
InflaRx is working to increase supply of the product in the US as quickly as possible.
The Simplist ready-to-administer prefilled syringes require no assembly or point-of-care preparation.