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Roche’s Actemra approved for severe COVID-19 in Europe

The monoclonal antibody previously used to treat inflammatory conditions such as rheumatoid arthritis is already being used in the US and Australia


The European Commission (EC) has extended the indication for Actemra/RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

The EC acted quickly after the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended the extension of the licence. Actemra/RoActemra is widely used to treat inflammatory conditions such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and cytokine release syndrome.

The US Food and Drug Administration issued an emergency use authorisation for the drug for the treatment of hospitalised adults and children aged two years and older back in June.

The COVID-19 indication is based on extensive data from four major trials, including the University of Oxford’s RECOVERY trial, the phase 3 study that looked at whether several potential treatments prevented death in hospitalised adult patients with severe COVID-19.

Together with three Roche-led phase 3 studies – COVACTA, EMPACTA and REMDACTA – data from more than 5,500 patients with severe or critical COVID-19 were reviewed by the CHMP.

In the main study, which involved 4,116 hospitalised adults with severe COVID-19, RoActemra plus standard treatment reduced the risk of death compared to standard treatment alone.

31% of RoActemra patients died within 28 days compared with 35% of patients receiving standard treatment alone, while 57% of RoActemra patients left hospital within 28 days compared with 50% on standard treatment alone.

“Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks,” said Dr Levi Garraway, Roche chief medical officer and head of global product development. The EMA approved Roche/Regeneron’s antibody cocktail, Ronapreve (casirivimab/imdevimab), in November.

“Together with vaccines, other treatments and testing, Actemra/RoActemra forms an important piece of the care puzzle as we confront new challenges of the pandemic in Europe and around the world,” said Dr Garraway.

While this data does not yet include Omicron, the new variant of concern, the World Health Organization has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are still expected to be effective in severe COVID-19. This conclusion was based on a prospective meta-analysis of almost 11,000 patients across 27 clinical trials published by in the Journal of the American Medical Association (JAMA).

Actemra/RoActemra is a co-development between Roche and Chugai. It was first approved in Japan in April 2005 and is currently available in more than 110 countries worldwide.

Article by
Hugh Gosling

8th December 2021

From: Regulatory



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