U.S. health regulators have approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
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 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.