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16-08-2021 15:39 |
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EMA
starts evaluating use of RoActemra in hospitalised adults with severe
COVID-19 |
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EMA has
started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to
extend its use to include treatment of hospitalised adult patients with
severe COVID-19 who are already receiving treatment with corticosteroids and
require extra oxygen or mechanical ventilation (breathing assisted by a
machine). 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. EMA’s
human medicines committee (CHMP) will carry out an accelerated assessment of
the data submitted in the application, including results from four large
randomised studies in patients hospitalised with severe COVID-19, to decide
whether the extension of indication should be authorised. The CHMP’s opinion,
together with any requirements for further studies and additional safety
monitoring, will then be forwarded to the European Commission, which will
issue a final legally binding decision applicable in all EU Member States. EMA will
communicate on the outcome of its evaluation, which is expected by
mid-October unless supplementary information is needed. RoActemra
was first authorised in the EU in 2009. More information about the medicine is available on the EMA
website. (MKY/EK) |
