The European Medicines Agency (EMA) recommended on Monday 6 December that the use of the anti-inflammatory drug RoActemra be extended to adult inpatients with severe Covid-19 “already receiving corticosteroid treatment and requiring supplemental oxygen or mechanical ventilation” (see EUROPE 12774/8).
This treatment, marketed by the German company Roche Registration GmbH, has been authorised in the EU since 2009 for the treatment of inflammatory diseases such as rheumatoid arthritis and juvenile idiopathic arthritis and polyarthritis.
The study on which the EMA based its decision showed that RoActemra, given as an infusion in addition to the treatment described above, reduced the risk of death compared to standard treatment alone, the agency said.
“Overall, 31% of patients treated with RoActemra in addition to standard therapy (621 out of 2022) died within 28 days of treatment, compared to 35% of patients receiving standard therapy alone (729 out of 2094). In addition, 57% of patients (1,150 out of 2,022) who received RoActemra were discharged from hospital within 28 days, compared to 50% of patients (1,044 out of 2,094) who received the standard treatment alone”, she said.
For more details: https://bit.ly/3uOMP9i (Original version in French by Agathe Cherki)