Roche announced on April 4, 2022 that FDA has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra/RoActemra intravenous for the treatment of COVID-19 in hospitalized adults. The treatment is for patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Actemra/RoActemra is currently approved for the treatment of COVID-19 in 16 countries, including the European Union. According to Roche, more than one million hospitalized patients with COVID-19 have been treated with Actemra/RoActemra worldwide. The treatment received Emergency Use Authorization from FDA in June 2021 and prequalification by the World Health Organization (WHO) for patients with severe or critical COVID-19 in February 2022. A decision on FDA approval is expected in the second half of 2022.
