America’s Food and Drug Administration (US FDA) granted the biotech company Genetech an Emergency Use Authorization (EUA) on June 24 for Actemra® (tocilizumab) for the treatment of COVID-19 patients. Actemra® is an anti-IL-6 receptor antibody developed by Dr. Tadamitsu Kishimoto, distinguished professor at Osaka University and 2020 Tang Prize winner for Biopharmaceutical Science, in collaboration with Japan’s Chugai Pharmaceutical Co.
When investigating the basic mechanisms of immune response, Dr. Kishimoto discovered a cytokine that regulates antibody production. That cytokine was later named interleukin-6 (IL-6). His group subsequently identified and cloned its receptor and demonstrated the involvement of IL-6 in the pathogenesis of various inflammatory diseases, including rheumatoid arthritis and juvenile arthritis. Based on this knowledge, they were able to successfully develop Actemra®.
Actemra® is administrated as an intravenous drip infusion. It can help reduce inflammation caused by IL-6 usually seen in patients with rheumatoid arthritis. It has been approved for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA)
According to the statement issued by the US FDA on June 24, Actemra® might be beneficial for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive ventilation, or extracorporeal membrane oxygenation (ECMO). It could help reduce the risk of death and speed up recovery. The data supporting this EUA are from four clinical trials: Randomized Evaluation of COVID-19 Therapy (RECOVERY), COVACTA, EMPACTA, and REMDACTA.