NUNZIUM

News That Matters

23.12.2022
THEME: HEALTH

FDA approved the first monoclonal antibody drug for the treatment of COVID-19 hospitalized patients

The FDA has approved Tocilizumab - also known as Actemra and commercialized by Roche Genentech - for treating hospitalized COVID-19 patients. The treatment is for individuals who receive corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or oxygenation. Tocilizumab is the first FDA-approved monoclonal antibody treatment for COVID-19, recommended for use as a single intravenous injection. Scientists evaluated Tocilizumab for the treatment of COVID-19 in 4 studies in more than 5500 individuals who were hospitalized. The studies showed that Tocilizumab may improve outcomes in individuals receiving corticosteroids and requiring supplemental oxygen or breathing support. There were no new warnings or precautions related to Tocilizumab noted in the trials, with the most common adverse events being anxiety, constipation, diarrhoea, hypertension, insomnia, nausea, and urinary tract infection. More than one million people hospitalized with COVID-19 have been treated with Actemra worldwide since the pandemic's beginning. Tocilizumab has been approved for use for COVID-19 in the United States, European Union, Japan, the United Kingdom, New Zealand, Russia, and Brazil. It is also provisionally approved in Australia and authorized for emergency use in Ghana, Mexico, and Korea for individuals hospitalized with severe or critical COVID-19. The World Health Organization has also recommended and prequalified the drug.