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The fight against COVID-19 continues and many companies and institutions are investing in vaccines and medicines to alleviate the pandemic. One of them is the pharmaceutical company Roche, which last Thursday (1) asked the National Health Surveillance Agency (Anvisa) to request an emergency use of a drug against COVID-19 that it is developing.
Roche’s bet consists of a combination of two biologics: casirivimab and imdevimab. In response to the request, Anvisa will begin sorting the documents, which should take at least 72 hours, as the company delivered more than 3,600 pages of data and information.
The general term for the full analysis is 30 days. It should be noted that Anvisa will be based on the technical report issued by the authority of the US Food and Drug Administration (FDA), the process data and the information presented in previous meetings with the pharmacist himself.
“If important information is missing, Anvisa can ask the laboratory. Anvisa acts in accordance with scientific and regulatory procedures, which must be followed by those seeking authorization for the drugs to be used in the Brazilian population, ”said the agency itself, in a note, according to Agência Brasil.
Meanwhile, the FDA statement said: “In a clinical trial of Covid-19 patients, casirivimab and imdevimab, administered together, have been shown to reduce hospitalization or emergency visits related to Covid-19 in patients with high risk of disease progression at 28 years days after treatment compared to placebo. The safety and efficacy of this experimental therapy for use in the treatment of Covid-19 continues to be evaluated. “
Source: Agência Brasil, CNN
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