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.
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Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
Findings showed that the trial did not meet statistical significance on the primary endpoint.
The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
The ACTT-2 study began on May 8 and included more than 1000 patients.
The placebo-controlled ACTT 3 trial will evaluate the efficacy and safety of remdesivir in combination with interferon beta-1a in more than 1000 hospitalized COVID-19 patients.
The FDA has approved Octapharma’s Investigational New Drug Application allowing the Company to initiate a phase 3 trial of Octagam® (immune globulin intravenous [human]) in patients with COVID-19 with severe disease progression.
Following clearance of an Investigational New Drug Application by the Food and Drug Administration, ViralClear announced that a phase 2 study evaluating merimepodib oral solution for the treatment of coronavirus disease 2019 (COVID-19) will be initiated.