Brazil’s health regulator authorizes emergency use of medicine against Covid-19

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) authorized the emergency use of an experimental drug – Sotrovimab – for treating patients with Covid-19, .

The drug was authorized for use in patients with mild to moderate symptoms and at risk of developing into a severe condition: for example, individuals who are 65 years of age and older or who have certain medical conditions. It is contraindicated for hospitalized patients who require ventilatory support.

The monoclonal antibody therapy manufactured by Glaxo Smith Kline LLC (GSK) was given emergency approval on May 26 by the U.S. FDA for the same conditions.

The drug will not be available for direct sale to the public, but will be for outpatient use, and must be prescribed by a physician to be administered. The product’s shelf life is 12 months, stored at temperatures ranging from 2º to 8ºC.

Authorization was unanimously approved by the ANVISA directorate. The rapporteur, Meiruze Freitas, pointed out that the technical areas assessed the data sent by the company responsible and considered them satisfactory.

“Regarding the clinical aspects, the efficacy results demonstrated that treatment with a 500 mg dose resulted in a clinical reduction with statistical significance in the proportion of volunteers with mild and moderate Covid-19 who took part in the trial,” Freitas said.

But she stressed that monitoring the drug’s administration is essential in order to detect adverse cases. Special attention was highlighted by the technical area for use in pregnant women, to whom the cost-benefit ratio must be carefully assessed.

The director also recalled that the European drug regulator has already issued an opinion supporting the use of Sotrovimab as a treatment option for Covid-19 adult and adolescent patients.

According to the ANVISA general manager of medicines and biological products, Gustavo Mendes, the treatment must be started soon after a positive test and, preferably, up to 5 days after the onset of symptoms. The drug is administered in a single 500 mg dose.

According to Mendes, clinical trials conducted with volunteers in the United States, Canada, and other countries, including Brazil, have shown results with “significant relevance” in reducing the viral load.

General Manager of Health Surveillance and Inspection Ana Carolina Marinho said that the production process was assessed, performed in two plants, one in China and another in Italy. “Information suggests acceptable compliance to justify the emergency use authorization in this pandemic scenario we find ourselves in,” she said.