Express Pharma

US FDA grants priority review to Roche’s Actemra/RoActemra to treat COVID-19 in hospitalised adults

If approved, Actemra/RoActemra would be the first US FDA-approved immunomodulator for the treatment of COVID-19 in hospitalised patients

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Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics Licence Application (sBLA), and has granted priority review for Actemra/RoActemra (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. A decision on the US FDA approval is expected in the second half of this year, Roche notified via a statement.

The sBLA submission is 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. Altogether, the