AMSTERDAM – The European Medicines Agency has started an accelerated review process to determine if a common pain-management drug might help people hospitalized with severe infectious-disease, months after the drug was granted an emergency use authorization in the U.S.
In a statement Monday, the EU drug regulator said it was assessing an application to extend the use of tocilizumab for adults suffering from severe coronavirus in the hospital, who were already being treated with other steroids or required extra oxygen, including via a ventilator. Tocilizumab is an anti-inflammatory drug currently used to treat adults and children with severe arthritis.
In June, the U.S. Food and Drug Administration granted the drug an emergency use authorization and the World Health Organization recommended its use last month for people who are critically ill with COVID-19. The European regulator said it expected to make a decision by mid-October on tocilizumab, based on data from four large studies. The drug was first licensed in the EU in 2009.
