Europe Recommends Inflammation Therapy for Severe COVID-19

The European Medicines Agency (EMA) human medicines committee announced it has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic therapy with corticosteroids and require supplemental oxygen or mechanical ventilation.

In reaching its conclusion, the EMA committee evaluated data from a study involving 4,116 hospitalized adults with severe COVID-19 who required extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood (indicating inflammation). 

The study showed that treatment with RoActemra given by infusion in addition to standard treatment reduces the risk of death when compared with standard treatment alone.

Overall, 31% of patients treated with RoActemra plus standard treatment died within 28 days of treatment compared with 35% of patients receiving standard therapy alone.

In addition, 57% of patients (1,150 out of 2,022) who received RoActemra were able to leave the hospital within 28 days compared with 50% of patients (1,044 out of 2,094) who received standard treatment alone.

RoActemra, marketed by Roche Registration GmbH, is already approved in Europe for treating the inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, and cytokine release syndrome.

RoActemra is an immunomodulating medicine that changes the immune system's activity.

The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein designed to attach to a specific target (called an antigen) in the body.

RoActemra attaches to the receptor for a messenger molecule or 'cytokine' called interleukin-6 (IL-6), produced by the body's immune system in response to systemic inflammation, which plays an important role in severe COVID-19 disease and associated respiratory failure.

By preventing IL-6 from attaching to its receptors, RoActemra reduces the inflammation and improves symptoms of severe COVID-19.

In the U.S., the FDA issued an Emergency Use Authorization for the use of ACTEMRA to treat COVID-19 in adult and pediatric patients (2 yrs+) who are in the hospital and who are receiving corticosteroids and require supplemental oxygen, or a machine that helps with their breathing, or a machine that adds oxygen to the blood outside the body (ECMO).

ACTEMRA is not FDA-Approved to treat COVID-19.