Genentech gets Actemra FDA approval for COVID-19 in hospitalized adults
Actemra FDA approval : Genentech, a subsidiary of Roche, has received the approval of the US Food and Drug Administration (FDA) for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19.
Actemra intravenous is indicated for the treatment of adult patients who are hospitalized and receiving systemic corticosteroids and supplemental oxygen.
Recommended for use as a single 60-minute IV infusion, Actemra is said to be the first FDA-approved monoclonal antibody for COVID-19.
Levi Garraway — Genentech Global Product Development head and chief medical officer said: “Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”
Actemra FDA approval was backed by the findings from the University of Oxford-led RECOVERY and the Genentech-sponsored EMPACTA trials, which demonstrated the efficacy and effectiveness of tocilizumab in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
Genentech gets Actemra FDA approval for COVID-19 in hospitalized adults. Photo courtesy of F. Hoffmann-La Roche Ltd.
In June 2021, the FDA granted Emergency Use Authorization (EUA) to Actemra in hospitalized adults and children aged two and older with COVID-19.
Actemra is approved for the treatment of COVID-19 in the US, the EU, Japan, the UK, Russia, New Zealand, and Brazil.
The intravenous treatment is provisionally approved in Australia, and authorized for emergency use in Ghana, Mexico, and South Korea for defined patients hospitalized with severe or critical COVID-19.
The World Health Organization recommended and prequalified Actemra, which was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with rheumatoid arthritis.