EU agency clears arthritis drug for severe Covid cases
The European Union’s drug regulator on Monday cleared the arthritis treatment tocilizumab for use in patients hospitalised with severe Covid-19, saying it reduced the risk of death.
The anti-inflammatory drug made by Swiss pharma giant Roche should be used with steroids for critically ill patients, the European Medicines Agency (EMA) said.
The World Health Organization and the United States have already endorsed the treatment, sold by Roche as RoActemra in Europe.
The EMA recommended extending tocilizumab’s use to include treating adults with Covid-19 who are receiving “systemic” steroid treatment and require extra oxygen or mechanical ventilation.
The European Commission must now formally approve the Amsterdam-based watchdog’s recommendation.
Previously approved for arthritis in adults and children, tocilizumab works by suppressing a dangerous “cytokine storm” over-reaction of the immune system to the coronavirus.
The drug, given intravenously or by injection, was found to reduce the risk of death and the length of time spent in hospital in a study of more than 4,000 patients with severe Covid-19, the EMA said.
But it should be given in tandem with corticosteroids as an “increase in mortality cannot be excluded” if used without them, it added.
The approval adds to the 27-nation EU’s anti-Covid toolbox, which already includes four vaccines, two antibody treatments including Roche’s Regeneron, and an emergency use green light for Merck’s anti-Covid pill.