A supplemental Biologics License Application (sBLA) for Roche’s Actemra/RoActemra intravenous treatment for COVID-19 cases among hospitalized patients was accepted by the United States Food and Drug Administration (FDA) this week and will benefit from priority review.
If approved, the drug would be the first immunomodulator authorized by the FDA to treat hospitalized COVID-19 patients. Specifically, it is meant for adults receiving systemic corticosteroids and in need of supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Additionally, the drug has successfully emerged from four randomized, controlled studies that tracked the treatment’s use on more than 5,500 patients.
“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Dr. Levi Garraway, Chief Medical Officer and head of Global Product Development for Roche. “More than 1 million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”
Actemra/RoActemra has been utilized to date through an Emergency Use Authorization granted by the FDA in June 2021 for the United States. It is also approved for use in 16 countries worldwide and earned prequalification from the World Health Organization (WHO) in February.
According to Roche, Actemra/RoActemra will also be provided at cost to WHO and its partners in the Access to COVID-19 Tools Accelerator (ACT-A) Initiative, which endeavors to get COVID-19 treatments and diagnostics dispersed more equitably. Roche announced that it expects an FDA decision on approval for the treatment in the second half of 2022.