Posted by Michael Wonder on 06 Dec 2021
EMA recommends approval for use of RoActemra in adults with severe COVID-19
6 December 2021 - The EMA’s 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 (indicating inflammation).
