FDA Grants Priority Review to Intravenous Treatment of COVID-19 in Hospitalized Adults
FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
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.
Roche is also aiming to establish a comprehensive access approach to improving the availability of its COVID-19 medicines around the world. The company is specifically focusing on providing Actemra/RoActemra via WHO and partners of the Access to COVID-19 Tools Accelerator (ACT-A) Initiative to low and middle-income countries, as well as implementing an international differentiated pricing strategy designed to improve accessibility and affordability worldwide.
“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 hospitalized with COVID-19,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release. “More than one 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.”
Source: Roche
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
