Gohibic is supplied as a 200mg/20mL solution in a single-dose vial for IV infusion after dilution.
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InflaRx is working to increase supply of the product in the US as quickly as possible.
The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
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.
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.