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
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 results of these four studies (Empacta, Covacta, Remdacta and Recovery) suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support, the statement added.
It also informed that in June 2021, Actemra/RoActemra received Emergency Use Authorisation (EUA) from the US FDA, and is currently approved for use in 16 countries around the world for defined patients hospitalised with severe or critical COVID-19. In February 2022, the World Health Organization (WHO) prequalified Actemra/RoActemra for patients with severe or critical COVID-19, supporting access to care in Low- and Middle-Income Countries (LMICs), the statement concluded.