Actemera receives FDA EUA to treat hospitalized COVID-19 patients

July 8, 20210

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Genentech’s arthritis drug, Actemra (tocilizumab) for hospitalized adults and pediatric patients (2 years of age and older), receiving systemic corticosteroids and in need of supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra has not been authorized for use in outpatients with COVID-19.  

Actemra (tocilizumab) is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. It is a prescription medication administered by intravenous infusion and is FDA-approved for multiple inflammatory diseases, including different forms of arthritis.   

The EUA is based on data of four clinical trials which included a randomized, controlled, open-label, platform trial, [Randomised Evaluation of COVID-19 Therapy (RECOVERY)] and three randomized, double-blind, placebo-controlled trials (EMPACTA, COVACTA and REMDACTA). COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), EMPACTA researched underserved populations through enrollment from minority patients often underrepresented, RECOVERY trial, 4,116 hospitalized patients with severe COVID-19 pneumonia in the UK and REMDACTA was conducted in collaboration with Gilead Sciences administrating actemra with Veklury (remdesivir).   

The phase III COVACTA (NCT04320615) Actemra did not meet its primary endpoint that is an improvement in the clinical status of hospitalized adult patients with severe COVID-19 associated pneumonia or secondary endpoints of difference in patient mortality at week four, but it displayed a positive trend in time to hospital discharge in patients treated with tocilizumab. Overall in the clinical trials, Actemra was tested in hospitalized COVID-19 patients who are on systemic corticosteroids and need additional oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Individuals treated with Actemra and the corticosteroid therapy, demonstrated reduction in the risk of death through 28 days of follow-up as well as a decrease in the duration of hospital stay through 28 days of follow-up. The issuance of an EUA is based on the totality of scientific evidence, and the known potential benefits of Actemra must outweigh the known and potential risks for the drug. 

As COVID-19’s severity has been marked by the increased level of interleukin-6 and c-reactive protein (CRP), hence, tocilizumab, which works on the mechanism of blocking IL-6 receptor as well as been approved for multiple inflammatory diseases, has been administered to multiple patients to address the cytokine storm. The Union Government of India permitted in July 2020 “investigational therapies” such as, Remdesevir, convalescent plasma and Tocilizumab for emergency use. 

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