Roche upgraded its emergency use authorization for Actemra in certain hospitalized Covid-19 patients to a full FDA approval, the company announced Wednesday, as cases climb in the US.
The approval comes roughly a year and a half after the monoclonal antibody treatment received an EUA to treat hospitalized patients 2 years and older who are also receiving systemic corticosteroids and require supplemental oxygen, ventilation or life support. While the approval is only for adults, Actemra will continue to be available for younger patients under the EUA.
With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,