The European Medicines Agency (EMA) supported on Thursday two new treatments for patients with covid-19 with monoclonal antibodies: Ronapreve, developed by the firms Regeneron and Roche, and Regkirona (regdanvimab), from the South Korean biopharmaceutical company Celltrion.
The EMA recommends to the European Commission support a license for these two COVID-19 treatments, which become the first monoclonal antibody drugs recommended for marketing authorization in the European Union (EU).
The drug Ronapreve, which combines the monoclonal antibodies casirivimab and imdevimab, is recommended to treat covid-19 in adults and adolescents over twelve years of age (and weighing at least 40 kg), who do not require supplemental oxygen and are at increased risk to develop a serious illness.
Last February, the EMA has already issued a scientific opinion valid for all EU countries that supports the use of the combination of casirivimab and imdevimab if they want to resort to it at the national level, considering that the reported side effects were mild or moderate, but that opinion was only seeking help national decision-making and was not today’s recommendation to license a specific pharmacist.
This drug, marketed in the United States by Regeneron, rose to fame when it was used as an experimental cocktail to treat former President Donald Trump when he was infected with it. SARS-CoV-2 last year.
As for Regkirona, the pharmaceutical company Celltrion Healthcare Hungary Kft, a European subsidiary of the South Korean company, requested a license in October with data supporting that regdanvimab is effective in treating adult patients who do not require supplemental oxygen and are at increased risk of develop severe symptoms.
Regdanvimab is a monoclonal antibody that reduces the ability of the virus to reach the cells of the body, reducing the need for hospitalization of patients with covid-19.
The EMA opened the process of continuous review of Regkirona last February, after the publication of the preliminary results of a study that analyzed the ability of the drug to treat the disease caused by the coronavirus, EFE reported.
The European agency is analyzing six other treatments for covid-19.
One of them is the oral antiviral drug molnupiravir (also known as Lagevrio or MK 4482), developed by the American pharmaceutical company Merck Sharp & Dohme in collaboration with the biotechnology company Ridgeback Biotherapeutics.
Studies suggest that it can reduce the ability of SARS-CoV-2 to multiply in the body, preventing hospitalization or death of infected adults, studies suggest.
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