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.
The update was based on data from the COV-BARRIER study.
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.
Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, appears to reduce respiratory distress as well as the hyperinflammatory immune response associated with coronavirus disease 2019.