The European Medicines Agency (EMA) announced this Thursday, November 11, that it has recommended the authorization of two drugs for Covid-19.
In a statement available on its official website, the EMA says that these are the first monoclonal antibodies recommended for marketing authorization.
The two approved drugs are Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), the first by pharmaceutical company Roche, Switzerland, and the second by Celltrion Healthcare, in South Korea.
For Ronapreve, the EMA recommended authorization for the treatment of Covid-19 in adults and adolescents (from 12 years and weighing at least 40 kg) who do not need supplemental oxygen and who are at increased risk of their disease if become serious.
The drug can also be used to prevent Covid-19 in people over 12, says the EMA on its official website.
As for Regkirona, the EMA also recommended authorizing the drug to treat adults with Covid-19 who do not need supplemental oxygen and who are also at increased risk of their disease becoming serious.
“Ronapreve and Regkirona are the first monoclonal antibody drugs to receive a positive opinion” says the Agency, explaining that the monoclonal antibodies “are proteins designed to attach to a specific target, in this case the spike protein of SRA-CoV-2, which the virus uses it to enter human cells”.
The EMA says it has looked at data from studies showing that treatment with the two drugs significantly reduces hospitalizations and deaths in patients with Covid-19.
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