First Monoclonal Antibody to Treat COVID-19 Approved

The first monoclonal antibody (mAbs) to treat COVID-19 has joined a short list of U.S. Food and Drug Administration (FDA) approved antivirals.

Roche announced yesterday that the FDA had approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Since the beginning of the pandemic in 2020, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide, said Roche's press release on December 21, 2022.

"With new variants emerging, FDA-approved treatments, including Actemra, remain essential to the continued fight against COVID-19," commented Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Roche's Global Product Development.

"Actemra is the first FDA-approved mAbs 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."

In the U.S., this is the seventh FDA-approved indication for Actemra since 2010.

The new approval follows the FDA's Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children (2 yrs.+) with COVID-19, granted in June 2021. 

The December 2022 approval is based on the results from the RECOVERY trial and the EMPACTA trial, the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups.

Actemra is recommended for use as a single 60-minute IV infusion.

No new warnings and precautions related to Actemra in COVID-19 studies have been identified.

Furthermore, the use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA-Approved.

Around the world, Actemra is approved for use in more than 30 countries. However, the EUA for this age group remains in place after yesterday's FDA approval for hospitalized adult patients. 

Moreover, the World Health Organization has prequalified Actemra for use in patients with severe COVID-19, facilitating its availability in low- and middle-income countries.

Currently, the U.S. Centers for Disease Control and Prevention lists oral Paxlovid®, Veklury, and Lagevrio as approved antivirals.

And in Europe, several antivirals have been authorized.

Actemra® (RoActemra®) was the first humanized interleukin-6 receptor antagonist approved for treating adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief. 

Roche continues to evaluate its therapeutic portfolio and is researching future options to help benefit patients with COVID-19.

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