The European Medicines Agency (EMA) approved, this Monday, the drug RoActemra, already used in inflammatory diseases, to treat severe cases of Covid-19 in adults.
"The EMA Committee for Human Medicines (CHMP) recommended extending the indication of RoActemra (tocilizumab) to include treatment of adults with Covid-19 who are receiving systemic corticosteroid treatment and need supplemental oxygen or mechanical ventilation," he said. the European regulator in a statement.
Following this EMA recommendation, it is now up to the European Commission to issue the final decision on the use of this drug for Covid-19 in Member States.
Marketed by Roche Registration GmbH, RoActemra is already approved in the European Union for the treatment of inflammatory diseases such as rheumatoid arthritis.
According to the European regulator, the CHMP evaluated data from a main study involving 4.116 adults hospitalized with severe Covid-19 who required oxygen or mechanical ventilation and with elevated levels of C-reactive protein in the blood (indicating inflammation).
The study data showed that treatment with RoActemra, an immunomodulator that alters the activity of the immune system and whose active substance is the monoclonal antibody tocilizumab, reduced the risk of death, as well as the length of hospital stay of patients infected with the coronavirus SARS-CoV-2.
The EMA is the body responsible for the scientific evaluation, supervision and monitoring of the safety of medicines in the EU, working in a network with thousands of experts from all over Europe, distributed among the various scientific committees.
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