On 7 December 2021, the European Commission expanded the conditions for use of the monoclonal anti-interleukin-6 receptor antibody RoActemra (tocilizumab). The drug is now approved for treatment of adults with severe COVID-19 who are being systemically treated with corticosteroids and require extra oxygen or mechanical ventilation. In approving the indication extension, the EU Commission followed the recommendation of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). The CHMP recommended the indication extension on 6 December 2021. RoActemra (tocilizumab) already has a marketing authorisation in the European Union for treatment of the inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and cytokine release syndrome (CRS).
Before making its recommendation to the European Commission, the CHMP evaluated data from a main study involving 4,116 hospitalised adults. All of the patients were suffering from severe COVID-19, required extra oxygen or mechanical ventilation, and had high blood levels of the C-reactive protein that indicates inflammation. The study showed that a treatment of RoActemra given by infusion, in addition to standard treatment, reduced the risk of death in comparison to standard treatment alone. In total, 31% of patients (621 out of 2,022) treated with RoActemra plus standard treatment died within 28 days of treatment compared with 35% of patients (729 out of 2,904) who only received standard treatment. In addition, 57% of patients who received RoActemra were able to leave the hospital within 28 days compared with 50% of patients who only received standard treatment.
For the use of RoActemra, it is important to note that only patients receiving systemic corticosteroids should receive it as an additional treatment. This is because an increase in the mortality rate cannot be completely ruled out for those patients not receiving corticosteroids. However, the safety profile of the drug was favourable when patients were already receiving treatment with corticosteroids. The CHMP concluded that the drug’s risk-benefit ratio is positive for this specific patient group. The European Commission followed the CHMP's recommendation and approved the indication extension.
The monoclonal antibody RoActemra (tocilizumab) is an immunomodulating drug, which means that it changes the activity of the immune system. RoActemra attaches to the interleukin-6 (IL-6) receptor. IL-6 is an important messenger molecule (called cytokine) produced by the body’s immune system as a reaction to inflammation throughout the body, known as systemic inflammation. This type of inflammation plays an important role in severe COVID-19 cases and respiratory failure associated with the disease. RoActemra prevents IL-6 from attaching to its receptors, thereby reducing inflammation and improving symptoms of severe COVID-19.
Updated: 09.12.2021
