The EMA (European Medicines Agency) began evaluating the anti-inflammatory drug RoActemra (tocilizumab) to extend its use to include treatment of adult patients with severe COVID-19 disease who are already being treated with corticosteroids and need extra oxygen or machine-assisted respiration.
According to the EMA announcement, RoActemra is considered a potential treatment for COVID-19 because of its ability to block the action of interleukin-6, a substance produced by the body’s immune system in response to inflammation, which plays an important role. in the coronavirus.
The EMA’s Committee for Human Medicines (CHMP) will conduct an expedited evaluation of the requested data, including results from four large randomized trials in patients with severe COVID-19, to decide whether to allow . The CHMP opinion, together with any requirements for further studies and additional security monitoring, will then be forwarded to the European Commission, which will issue a final legally binding decision valid in all EU Member States.
The result of the evaluation of Coreper is expected by mid-October, unless additional information is required.
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