European Medicines Agency Supports Ronapreve and Regkirona COVID-19 Treatments

The European Medicines Agency (EMA) on Thursday endorsed two new treatments for patients with the 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 that the European Commission endorse a license for these two treatments for COVID-19, 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 12 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 already issued a valid scientific opinion 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 intended to help national decision-making and was not today’s recommendation to license a specific pharmaceutical company.

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 became infected with 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 Regkirona’s ongoing review process last February, after the publication of preliminary results of a study that analyzed the drug’s ability to treat the disease caused by the coronavirus.

The European agency is looking at 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.