Roche requests Anvisa to use emergency drugs against Covid-19



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Injection for drug administration
Injection for drug administration
Photo: Fotoblend / Pixabay

The National Health Surveillance Agency (Anvisa) received on Thursday (1) the request for emergency use of a drug by the pharmaceutical company Roche against Covid-19.

It is a cocktail that contains casirivimab and imdevimab, two experimental remedies developed by the American biotech company Regeneron and produced in association with the French giant. The application is intravenous.

The drug has already received the emergency seal of approval from the Food and Drug Administration (FDA), the US regulatory agency, after presenting good results in patients with mild and moderate symptoms of Covid-19.

“In a clinical trial of patients with Covid-19, it was shown that casirivimab and imdevimab, administered together, reduce hospitalization or emergency visits related to Covid-19 in patients at high risk of disease progression within 28 days post-treatment compared to placebo … The safety and efficacy of this experimental therapy for use in the treatment of Covid-19 continues to be evaluated, “says the FDA statement.

In Brazil, Anvisa will use the FDA report as a reference, but has its own process to approve the drug. The process can take up to 30 days after the agency clarifies its technical doubts with the laboratory.

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