The Swiss pharmaceutical group Roche announced on Monday that the United States Medicines Agency had granted “priority review” status to its drug tocilizumab intended for patients hospitalized with COVID-19 infection.
This status is reserved for drugs intended for serious diseases for which there are few treatment options, with a view to examining their application for approval as a priority.
If approved, the drug marketed by country name Actemra or RoActemra would be the first immunomodulator approved in the United States for patients hospitalized with COVID-19 infection, Roche said in a statement.
The decision of the American drug agency, the Food and Drug Administration (FDA), is expected during the second half of 2022, added the Swiss group.
Roche has filed for approval for this intravenous therapy for hospitalized adult patients on corticosteroids who require oxygen. This application was filed on the basis of four studies conducted with 5,500 hospitalized patients.
Since the start of the pandemic, more than a million people hospitalized with COVID-19 have been treated with this monoclonal antibody used for the treatment of rheumatoid arthritis.
In the United States, tocilizumab has already been used to treat hospitalized patients based on an emergency authorization granted in June 2021.
In February, the World Health Organization (WHO) had prequalified tocilizumab to treat patients with severe forms of COVID-19 in order to make this treatment more accessible to low-income countries.