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An accelerated assessment by the EMA’s CHMP reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU marketing authorisation for Roche’s Actemra/RoActemra (tocilizumab) to treat adult Covid-19 patients.
Actemra/RoActemra reduced the risk of death in patients with severe COVID-19, as evidenced by a review of four phase-III studies. The European Commission is expected to make a final decision regarding approval in the near future.