The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19.
For months already, the medicine has been given to severely ill COVID-19 patients on a compassionate-use basis, generating hundreds of millions in sales for Roche.
The drug can be used to treat patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, the FDA said, adding studies showed Actemra helped reduce the risk of death and speed recovery.
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, Roche said.
In the first quarter, Actemra sales rose 22% to 779 million Swiss francs ($850 million), after surging nearly a third to 2.9 billion francs in 2020, mostly due to treatment of patients with severe COVID-19-associated pneumonia.
Though rising vaccinations in places such as Europe and the United States are reducing hospitalizations for COVID-19, Actemra is still being deployed for certain patients who land in the hospital.
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease,” said Levi Garraway, the company’s chief medical officer.
Testing Actemra for COVID-19 patients involved trial and error, as successes in studies underpinning the FDA’s EUA were accompanied by several failures in different patient groups as the Swiss company gathered knowledge about just who would benefit.
Actemra is not authorized for use in outpatients with COVID-19 or as a treatment for COVID-19, the health agency said.
Last year, the FDA approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, but a trial mixing Actemra with remdesivir failed to cut hospital stays.