Brazil’s health regulator denies approval of Avifavir, Russian antiviral against Covid-19

RIO DE JANEIRO, BRAZIL – According to the vote of Director Meiruze Freitas, the drug does not meet the health regulator Anvisa’s expectations in terms of minimum safety and efficacy requirements in the context of emergency use.

“You cannot approve the use of a drug that has not shown clinical benefit in the treatment of Covid-19 and yet can lead to health risks for patients,” she said.

The drug, manufactured by Russian companies API – Technologies LLC and Joint Stock Company Chemical Diversity Research Institute – JSC CDRI, had registered the application for emergency use approval by the Vital Brazil Institute.

Avifavir is considered a new drug whose active pharmaceutical ingredient has not yet been registered by Anvisa.

In Brazil, the drug rendesivir and two monoclonal antibody dressings, consisting of casirivimab with imdevimab and banlanivimab with etesevimab, are already indicated for the treatment of Covid-19.

To date, no regulatory agency in the world has approved avifavir (favipiravir) for the treatment of Covid-19, Anvisa says.

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