The European Medicines Agency will now send its recommendation
to the European Commission, which will issue a final decision
The European Medicines Agency (EMA) has recommended extending the indication of tocilizumab, a drug marketed by Roche, (already approved for the treatment of inflammatory conditions of rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and cytokine release syndrome) a
nthan to treating adults with
severe forms of Covid-19, who are receiving corticosteroid treatment and require supplemental oxygen or mechanical ventilation.
The drug has been studied for some time for its possible use in the most severe forms of Covid with rnegative results, but also with openings in the direction of the need further research and insights
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I study
Now comes the opinion of the EMA. To reach its conclusions, the European Agency has evaluated the data of a study that involved 4,116 hospitalized adults with severe Covid-19 who needed extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood (an indicator of inflammation). The study showed that con this treatment administered by infusion, in addition to the usual therapies, the risk of death is reduced by a few percentage points. Overall, 31% of patients treated with standard treatment tocilizumab pi (621 out of 2,022) died within 28 days of therapy, compared with 35% of patients treated with standard treatment alone (729 out of 2,094). Additionally, 57% of patients (1,150 of 2,022) who received tocilizumab managed to leave the hospital within 28 days compared with 50% of patients (1,044 of 2,094) who received standard treatment alone. The study indicated that an increase in mortality cannot be excluded when using tocilizumab in patients not receiving systemic corticosteroids. Conversely, the safety profile was favorable for those already receiving corticosteroid treatment.L
’Ema will now send its recommendation to the European Commission, which will issue a final decision
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The mechanism of action
The drug works by binding to the interleukin-6 (IL-6) receptor, a mediating protein (cytokine) produced by the immune system in response to a systemic inflammatory process, which plays a key role in severe Covid patients and respiratory failure associated with the disease. By preventing IL-6 from binding to its receptors, tocilizumab reduces inflammation and improves symptoms in severe patients.
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December 6, 2021 (change December 6, 2021 | 17:46)
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