Brazil can already start testing with remdesivir, an antiviral medication, in the treatment of patients with COVID-19, according to a statement made by the Brazilian Health Regulatory Agency (Anvisa) on Wednesday (25).
Anvisa also announced that the study to be carried out in the country will be phase 3, which involves the observation of patients who are being treated with the drug. People who are already hospitalized with severe pneumonia caused by the new coronavirus will receive the drug, divided into two groups.
The first will be treated with remdesivir combined with another medication called tocilizumab, which acts in the body as an immunoregulator and is used against rheumatoid arthritis. The second group will receive remdesivir given with a placebo. The idea is that in Brazil, according to authorization requested by the company PPD do Brasil Suporte a Pesquisa Clínica Ltda, 105 patients pass the test.
Approval in Europe
Remdesivir has also received approval from the European Medicines Agency (EMA), which can now be prescribed for patients diagnosed with COVID-19, requiring mechanical breathing, and who are 12 years of age or older. It is up to the European Commission to finalize the authorization in a bureaucratic manner, which should happen within a week. Once approved, the indication of the drug will be in force in 27 countries and will be valid for one year.
As there is still no proof that the drug is really effective against COVID-19, the North American pharmaceutical manufacturer Gilead needs to inform the European Union of the results of the remdesivir tests, as well as their side effects, by December.
What is Remdesivir for?
Remdesivir is an antiviral developed to combat Ebola, but which has already shown positive results in the treatment of other types of coronavirus, responsible for SARS and MERS diseases. In the United States, the drug has already been approved for serious patients in COVID-19, shortly after authorization by the regulatory agency Food and Drug Administration (FDA).
According to the FDA, the criterion used to approve the drug was a study by the American National Institute of Health (NIH), which conducted tests on 1,063 patients not only in the United States, but in Asia and Europe. The result showed that people treated with remdesivir recovered about four days before those who did not receive the drug. In early June, South Korea and India also began testing the drug.
News from: Canal Tech