European Medicines Agency supports use of RoActemra in adults with severe COVID-19

The European Medicines Agency (EMA) endorsed the use of RoActemra (tocilizumab) – used in patients with rheumatoid arthritis – to treat adults with severe COVID-19 who are receiving corticosteroid treatment and need supplemental oxygen.

The Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication of RoActemra, already authorized in the European Union (EU) to treat inflammatory diseases, and thus include COVID-19 in adults who require supplemental oxygen or mechanical ventilation, and that are already receiving systemic corticosteroid therapy.

To support the anti-COVID-19 use of the drug, marketed by Roche Registration GmbH, the CHMP evaluated data from a main study involving 4,116 critically ill hospitalized adults who required additional oxygen or mechanical ventilation and had elevated protein levels. C reactive in the blood (symptom of inflammation).

“Overall, 31% of patients treated with RoActemra plus standard treatment (621 of 2,022) died within 28 days of treatment compared to 35% of patients who received standard treatment alone (729 of 2,094)”, Says the agency.

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

The conclusions reached by the CHMP are now sent to the European Commission, which has the last word in issuing a final decision that is legally binding and applicable in all EU Member States.

The use of RoActemra has already been authorized in the EU since 2009 to treat, among others, adults with moderate to severe rheumatoid arthritis or children from one year of age with systemic juvenile idiopathic arthritis, in which other treatments have not worked as well. well enough.