The US Food and Drug Administration (FDA) has approved tocilizumab (Actemra) as the first monoclonal antibody to be granted full FDA approval for the treatment of COVID-19 in hospitalized adults. This medication is recommended for use as a single 60-minute IV infusion in patients receiving systemic corticosteroids and who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The approval of Actemra was based on data from four randomized, controlled clinical trials involving over 5500 hospitalized patients. These trials were conducted as part of the RECOVERY and phase EMPACTA trial. Prior to full FDA approval, tocilizumab had already been granted Emergency Use Authorization (EUA) to treat adults and children aged 2 and above with COVID-19 in June 2021. According to Roche's chief medical officer and head of Global Product Development, Levi Garraway, MD, PhD, “Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.” Tocilizumab has also been approved for other conditions in the past, including systemic sclerosis-associated interstitial lung disease in March 2021 and various forms of psoriatic and rheumatic arthritis.
The US Food and Drug Administration (FDA) has recently approved tocilizumab (Actemra) for the treatment of COVID-19 in hospitalized adults. This is the first monoclonal antibody to be granted full FDA approval for the pandemic virus. The medication is recommended for use as a single 60-minute IV infusion in patients receiving systemic corticosteroids and who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The approval of the monoclonal antibody was based on data from four randomized, controlled clinical trials involving more than 5500 hospitalized patients that were conducted as part of the RECOVERY and phase EMPACTA trial. Prior to full FDA approval, tocilizumab had already been granted Emergency Use Authorization (EUA) in June 2021 to treat adults and children aged 2 and above with COVID-19. According to Roche's chief medical officer and head of Global Product Development, Levi Garraway, MD, PhD, “Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.” In addition, tocilizumab has been approved for other conditions in the past, such as systemic sclerosis-associated interstitial lung disease in March 2021 and various forms of psoriatic and rheumatic arthritis.
The US Food and Drug Administration (FDA) has recently approved tocilizumab (Actemra) for the treatment of COVID-19 in hospitalized adults. This is the first monoclonal antibody to be given full FDA approval to treat the pandemic virus. The medication is used as a single 60-minute IV infusion in patients receiving systemic corticosteroids and who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The approval is based on data from four randomized, controlled clinical trials involving more than 5500 hospitalized patients, part of the RECOVERY and phase EMPACTA trial. It had previously been granted Emergency Use Authorization (EUA) in June 2021 to treat adults and children aged 2 and above with COVID-19. According to Roche's chief medical officer and head of Global Product Development, Levi Garraway, MD, PhD, “Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.” In addition, tocilizumab has been approved for other conditions, including systemic sclerosis-associated interstitial lung disease in March 2021 and various forms of psoriatic and rheumatic arthritis.
The US Food and Drug Administration (FDA) has recently granted full approval to tocilizumab (Actemra) for the treatment of COVID-19 in hospitalized adults. This is the first monoclonal antibody to be approved by the FDA for this purpose. The medication is recommended as a single 60-minute IV infusion for patients receiving systemic corticosteroids and who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The approval was based on data from four randomized, controlled clinical trials involving more than 5500 hospitalized patients.