The US Food and Drug Administration has issued an emergency use authorization for the drug Actemra for the treatment of hospitalized COVID-19 adults and pediatric patients. The authorization was issued on Thursday to Genentech, a subsidiary of Roche Holding AG. The drug can be used to treat patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. The FDA also said that Actemra helped reduce risk of death and speed recovery citing scientific studies. The EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients, Roche said. "Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "We are pleased that Actemra/RoActemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States." — Agencies
