EMA Expands Authorization for Roche’s Actemra/RoActemra in COVID

The European Commission has extended the marketing authorization for Roche’s Actemra/RoActemra (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
The decision from the European Commission follows an accelerated assessment by the EMA ’s CHMP , which reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19. These include the Roche-led Phase III COVACTA, EMPACTA and REMDACTA trials, and the University of Oxford’s Randomized Evaluation of COVID-19 Therapy (RECOVERY) study, which was supported by Roche.

Outside of the EU, Actemra/RoActemra has been provisionally approved in Australia, authorized for emergency use in the U.S. and Ghana, and recommended by the World Health Organization (WHO) for the treatment of COVID-19. Roche is working with regulatory bodies and other partners around the world on the next steps to bring this medicine to as many people as possible.
Following the recent emergence of the new SARS-CoV-2 variant of concern, Omicron (B.1.1.529), WHO has reported that interleukin 6 Receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.
Actemra/RoActemra was the first approved anti-IL-6 receptor Biologic and is available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA).