Europe Evaluates Rheumatoid Arthritis Treatment for Severe COVID-19

The European Medicines Agency (EMA) announced it had started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalized adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation.

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 COVID-19.   

RoActemra is a medicine used to treat rheumatoid arthritis and contains the active substance tocilizumab.

RoActemra can also be used in adults and certain children to treat life-threatening cytokine release syndrome, a condition that can cause nausea, vomiting, pain, and low blood pressure.

It was first authorized in the EU in 2009.

The EMA’s human medicines committee confirmed it would carry out an accelerated assessment of the data submitted in the application, including results from four large randomized studies in patients hospitalized with severe COVID-19, to decide whether the extension of indication should be authorized.

The EMA stated in a press release issued on August 16, 2021, it will communicate the outcome of its evaluation, which is expected by mid-October 2021 unless supplementary information is needed.