EMA recommends approving RoActemra medicine to help treat severe Covid-19 cases

European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends expanding the use of RoActemra (tocilizumab) and include treatment of severe Covid-19 infection cases for patients who receive corticosteroids and who require oxygen treatment or artificial lung ventilation, reports EMA.
Roche Registration GmbH manufactured RoActemra. This medicine was previously approved for use in the EU to treat inflammatory diseases, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arthritis.
Covid-19 research data
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 (indicating inflammation).
This research showed that treatment using RoActemra using infusion method on top of the standard treatment method helps reduce the risk of death when compared to only standard treatment.
Overall 31% of patients treated with RoActemra plus standard treatment (621 out of 2 022) died within 28 days of treatment compared with 35% of patients receiving standard treatment alone (729 out of 2 094).
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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.
More about RoActemra
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, 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.
More information about the evaluation of RoActemra and the approved product information are available on the medicines page for RoActemra on EMA’s website.
The CHMP will send its recommendation for Covid-19 to the European Commission, which will issue a final decision.
Specialists from Latvia’s State Agency of Medicines also participate in scientific committees and work groups of the European Medicines Agency