- The authorisation enables emergency use of Actemra/RoActemra for the treatment of COVID-19 in hospitalised adult and paediatric patients
Basel, 25 June 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. The results of these studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
“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,” 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 authorised as an option that may help improve outcomes for adults and children hospitalised with COVID-19 in the United States.”
The four randomised, controlled studies included in the EUA submission investigated the safety and efficacy of Actemra/RoActemra in more than 5,500 hospitalised patients with COVID-19. The RECOVERY Actemra/RoActemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalised COVID-19 patients. Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. There have been no new safety signals identified for Actemra/RoActemra in any of these studies. The most common adverse reactions seen (incidence ≥ 3%) are constipation, anxiety, diarrhoea, insomnia, hypertension and nausea.
The U.S. FDA Letter of Authorisation and Fact Sheets for patients and health care professionals are available for download with the latest information on this EUA. For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.