EMA Commences Evaluation of RoActemra as COVID-19 Treatment

The European Medicines Agency (EMA) announced in an Aug. 16, 2021 press release that it has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19 who are already undergoing corticosteroid treatment and require extra oxygen or mechanical ventilation.

According to the press release, RoActemra is being considered as a potential treatment for COVID-19 as a result of the therapy’s ability to block the action of interleukin-6, which is a substance that the immune system produces in response to inflammation. EMA’s Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data that has been provided within the application, which include results from four large, randomized studies.

During its review, CHMP will discern whether or not an extension of indication for RoActemra is suitable and will provide its opinion, along with any recommendations for further studies or additional safety monitoring, to the European Commission. The commission will make the final legally binding decision on the indication extension, which will apply to all European Union member states.

Further information on the progress of the assessment and the outcome will be communicated by EMA. The agency expects to be able to provide an update by mid-October unless additional information is required.

Source: EMA