FDA grants Roche’s Actemra/RoActemra EUA for hospitalised adults and paedriatrics with Covid-19

The FDA has issued an Emergency Use Authorization for intravenous Actemra/RoActemra® (tocilizumab) for treating hospitalised adults and paediatric patients with Covid-19 where they are given systemic corticosteroids and need additional oxygen, extracorporeal membrane oxygenation, or non-invasive/invasive mechanical ventilation. The approval came on the back of results from four randomised, controlled studies, RECOVERY, EMPACTA, COVACTA and REMDA, that investigated the safety and efficacy of Actemra/RoActemra in over 5,500 hospitalised patients with Covid-19 that concluded Actemra/RoActemra could possibly improve outcomes in such hospitalised patients. The RECOVERY Actemra/RoActemra study, was led by researchers in the UK. There have been no new safety signals identified for Actemra/RoActemra in any of these studies, and the most common adverse reactions recorded were nausea, constipation, diarrhoea, insomnia, hypertension and anxiety.

Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, 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 hospitalisations from severe forms of the disease. We are pleased that Actemra/RoActemra is now authorised as an option that may help improve outcomes for adults and children hospitalised with COVID-19 in the United States.”