Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19

发布时间： 2021-06-29 阅读：516次

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26 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 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.

“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.”