Roche has announced that the US Food and Drug Administration (FDA) has formally approved its phase 3 trial of Actemra in severely ill COVID-19 patients, who have been hospitalised with pneumonia.
Actemra (tocilizumab) – an interleukin-6 inhibitor – has already been approved in China for the treatment of patients infected with the novel coronavirus disease, who have developed serious lung damage and also have elevated levels of IL-6 in the blood.
Previous research has suggested that elevated IL-6 – a biomarker for inflammation and a high-level immune response – is associated with a higher mortality in people with community-acquired pneumonia.
The investigation of Actemra's use in COVID-19 is based on the hope that the drug could interrupt the process of ‘cytokine release syndrome’ (CRS), a form of serious inflammatory response that can occur as a complication of some infections.
It was first cleared by the FDA as a treatment for rheumatoid arthritis and has also subsequently been approved in juvenile idiopathic arthritis, giant cell arteritis and CRS associated with CAR-T cell therapies for cancer.