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Covid-19: Roche requests marketing of its synthetic antibody cocktail

2021-10-11T19:56:56.014Z

The European Medicines Agency (EMA) received a request from the Swiss pharmaceutical group Roche for an EU marketing of Ronapr



The Swiss pharmaceutical laboratory Roche has submitted an application for the marketing in the European Union of its cocktail of synthetic antibodies against Covid-19 Ronapreve.

The Amsterdam-based European Medicines Agency (EMA) announced this on Monday.

The World Health Organization (WHO) recently officially recommended this treatment for Covid-19, but only in specific cases.

Designed by the biotechnology company Regeneron and marketed by the Roche laboratory under the name Ronapreve, this treatment combines two antibodies (called “monoclonal”) manufactured in the laboratory, casirivimab and imdevimab.

When injected intravenously, they are supposed to support the immune system to neutralize the coronavirus.

An opinion expected within two months

"The EMA begins to assess a marketing authorization application for the combination of Ronapreve monoclonal antibodies (casirivimab / imdevimab)," the Amsterdam-based European Medicines Agency (EMA) said in a statement. .

She "could issue an opinion within two months," she added.

The Ronapreve injectable treatment "is intended for the treatment of Covid-19 in adults and adolescents from 12 years of age who do not need additional oxygen therapy and who present an increased risk of progressing to a severe stage", a indicated the EMA.

Treatment given to Trump

It is also intended "for the prevention of Covid-19 in adults and adolescents aged 12 and over," she added.

The former President of the United States, Donald Trump, had received this treatment when he caught the Covid in September / October 2020. In recent months, NGOs have denounced the high price of Ronapreve, which they estimated at around 2,000 dollars (1,700 euros) per dose.

A marketing authorization application is the last step in which the EMA's Committee for Medicinal Products for Human Use carries out a final scientific assessment before making a recommendation to the European Commission.

Source: leparis

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