On Jun. 25, 2021, Roche announced that the Food and Drug Administration (FDA) had 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 was 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.

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 had 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.

Actemra/RoActemra had not been approved by the U.S. FDA in this setting, but the U.S. FDA made Actemra/RoActemra available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19. There was limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The authorisation is temporary and does not replace the formal review and approval process. Actemra/RoActemra is authorised under the EUA only for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of Actemra/RoActemra under Section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorisation is terminated or revoked sooner. Roche has existing distribution channels established to ship Actemra/RoActemra to hospitals across the United States.