Genetech’s medicine receives FDA EUA for the treatment of COVID-19 in hospitalized adults and children

June 28, 2021

On June 24, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for intravenous Actemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), reported Genetech.

Actemra is not FDA-approved for this use. The EUA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used under the EUA).

The EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results of these studies suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

There is limited information known about the safety or effectiveness of using ACTEMRA to treat people in the hospital with COVID-19. The safety and effectiveness of ACTEMRA have not been studied in pediatric patients hospitalized with COVID-19.

ACTEMRA can cause serious side effects. The most important side effects include:

·        Serious infections

·         Tears (perforation) of the stomach or intestines

·         Liver problems (hepatotoxicity)

·         Changes in certain laboratory test results including low neutrophil (white blood cells that help the body fight off bacterial infections) or platelet (blood cells that help with blood clotting and stop bleeding) counts or high liver function tests

Genetech has the brief.

More COVID-19 coverage HERE.