FDA issues EUA for monoclonal antibody for treatment of hospitalized COVID-19 patients

By Samantha Black, PhD, ScienceBoard editor in chief

June 25, 2021 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Genentech, a member of the Roche Group, for tocilizumab (Actemra).

The drug is for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

In COVID-19 clinical trials, Actemra was shown to reduce the risk of death through 28 days of follow-up and decreased the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.

Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. It does not directly target SARS-CoV-2, rather it is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.

Under the EUA, the FDA is authorizing the emergency use of Actemra for the treatment of certain hospitalized patients with COVID-19.

Actemra is not approved for the treatment of COVID-19. However, the agency has determined that it is reasonable to believe that the drug may be effective in treating COVID-19 for the authorized population. And when used to treat COVID-19 for the authorized population, the known and potential benefits of Actemra outweigh the known and potential risks for the drug.

The data to support the EUA are based on four clinical trials, which include one randomized, controlled, open-label, platform trial and three randomized, double-blind, placebo-controlled trials.

The agency's decision was primarily based on data from the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial and the EMPACTA trial.

The RECOVERY trial evaluated the drug among 4,116 hospitalized patients with severe COVID-19 pneumonia who received Actemra in addition to usual treatment or only usual treatment, and the EMPACTA trial evaluated 389 hospitalized patients with COVID-19 pneumonia who received either Actemra or a placebo.

Do you have a unique perspective on your research related to infectious diseases? Contact the editor today to learn more.

---




Copyright © 2021 scienceboard.net
 
To access all The ScienceBoard content create a free account now:


Email Address:  

First Name:

Last Name:

Learn about ScienceBoard

Get the latest life sciences research and industry news, delivered straight to your inbox, for free.

Why subscribe?

ScienceBoard is uniquely focused on the business of research, addressing the biggest problems that the biomedical industry face. You’ll get breaking news, events coverage, and deep dives into the science that drives innovation, delivered to your inbox daily.


Letter from the Editor Please send me twice-weekly roundups of all the latest life research and industry news.
SAB Announcements Please send me the latest announcements from The Science Advisory Board and their partners.
Spotlight Receive notifications about new content, services, or educational resources designed to help you sharpen your skills and grow professionally.
 
I have read and agree to the privacy policy and terms of service and wish to opt-in for ScienceBoard.net.

Already have an account? Sign in here