US FDA Approves Roche’s COVID-19 Antibody Treatment


Roche reported that the U.S. Food and Drug Organization (FDA) has supported Actemra intravenous for the treatment of Coronavirus in hospitalized grown-up patients who are getting foundational corticosteroids and require supplemental oxygen, painless or obtrusive mechanical ventilation, or extracorporeal film oxygenation (ECMO). Actemra is the first monoclonal antibody for COVID-19 treatment that has been approved by the FDA. It should be administered intravenously once every 60 minutes.

According to Levi Garraway, Chief Medical Officer and Head of Global Product Development, “FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19” in light of the emergence of new variants. Actemra is the first monoclonal antibody for treating severe COVID-19 that has been approved by the FDA. This gives hospitalized patients and their healthcare providers, who continue to treat COVID-19 on the front lines, an important option.

Actemra’s efficacy for the treatment of COVID-19 in more than 5,500 hospitalized patients was examined in four randomized, controlled trials. Overall, the studies revealed that Actemra may improve outcomes in corticosteroid-treated patients who also require oxygen support or supplemental oxygen.

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The EMPACTA trial, the first global Phase III COVID-19 study to focus on patients from underrepresented racial and ethnic groups, provided the basis for the FDA’s approval. COVID-19 studies have found no new Actemra-related warnings or precautions.

The Emergency Use Authorization (EUA) granted by the FDA in June 2021 for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19 follows the FDA’s approval. The utilization of Actemra to treat hospitalized individuals ages 2 to under 18 years of age isn’t FDA endorsed, but the EUA for this age bunch presently stays set up after the FDA endorsement for hospitalized grown-up patients.

Since the beginning of the pandemic, Actemra has been administered to over one million COVID-19-infected patients worldwide. Actemra is approved for use on hospitalized patients with severe COVID-19 in more than 30 nations. Since the medication’s introduction in 2010, this is the seventh indication for Actemra that has been approved by the FDA in the United States.

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In the fight to end the COVID-19 pandemic, Roche stands with society, governments, healthcare providers, and everyone else.


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