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Plenary.News – 03/04/2021 11:31 am | updated on 04/03/2021 12h10
The chemical and pharmaceutical company Roche has submitted an application for the emergency use of a drug against Covid-19. The National Health Surveillance Agency (Anvisa) will evaluate the request within 30 days, in case it is not necessary to request additional documentation to complete the technical analysis.
According to a press release, the drug is the result of the combination of two biological drugs (casirivimab + imdevimab). Anvisa informs that the first 72 hours will be used to filter the process and verify if the necessary documents are available.
Roche provided 3,626 pages of data and information about the drug. If important information is missing, Anvisa can ask the laboratory. To carry out the evaluation, Anvisa will use the technical report issued by the US authority (Food and Drug Administration – FDA).
According to the information available on the website of the Swiss group Roche, the cocktail of drugs against Covid was tested in approximately 23,000 people in clinical trials conducted in February 2021. The trials were conducted in outpatients and selected hospitalized patients, including the open trial in hospitalized. patients in the UK and a trial for the prevention of Covid-19.
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