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(RTTNews) – The U.S. Food and Drug Administration has approved Roche’s (RHHBY) Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), the company said in a statement on Wednesday.
Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.
The FDA approval follows the FDA’s Emergency Use Authorization for Actemra in hospitalised adults and children (ages 2 and older) with COVID-19, which was granted in June 2021.
The use of Actemra to treat hospitalised people ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group currently remains in place after the FDA approval for hospitalised adult patients.
Around the world, Actemra is approved for use in more than 30 countries for patients hospitalised with severe COVID-19. In the United States, this is the seventh FDA approved indication for Actemra since the medicine was launched in 2010.
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