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

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.

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By: Kristin Brooks

Managing Editor, Contract Pharma

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...

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