EMA recommends RoActemra in adults with severe COVID-19
Posted: 9 December 2021 | Anna Begley (European Pharmaceutical Review) | No comments yet
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra’s indication to include COVID-19 patients receiving systemic treatment.
The European Medicines Agency (EMA)’s human medicines committee , the Committee for Medicinal Products for Human Use (CHMP), has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation.
In reaching its conclusion, the CHMP evaluated data from a main study involving 4,116 hospitalised adults with severe COVID-19 who required extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood.
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 percent of patients treated with RoActemra plus standard treatment (621 out of 2,022) died within 28 days of treatment compared with 35 percent of patients receiving standard treatment alone (729 out of 2,094). In addition, 57 percent of patients (1,150 out of 2,022) who received RoActemra were able to leave the hospital within 28 days compared with 50 percent of patients (1,044 out of 2,094) who received standard treatment alone.
The study also indicated that an increase in mortality cannot be excluded when using RoActemra in patients who are not receiving systemic corticosteroids. However, the safety profile of the medicine was favourable in those who are already receiving treatment with corticosteroids and the CHMP concluded that the medicine’s benefits are greater than the risks for these patients.
RoActemra is an immunomodulating medicine (a medicine that changes the immune system 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). IL-6 is produced by the body’s immune system in response to systemic inflammation (inflammation throughout the body), 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.
The medicine, marketed by Roche Registration GmbH, is already approved in the EU for treating the inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and cytokine release syndrome (CRS).
Clinical Trials, Data Analysis, Drug Safety, Regulation & Legislation, Therapeutics, Viruses
Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), Roche