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EU approves two new antibody treatments

Two antibody therapy medications to combat COVID-19 have won approval from the European Medicines Agency (EMA), the body has announced.

The EMA recommends authorising Ronapreve from Swiss pharmaceutical company Roche and Regkirona from South Korea’s Celltrion.

Both are recommended for use in the early stages of infection.

The European Commission must give its blessing before the two drugs can hit the EU single market but this is considered a formality.

Ronapreve consists of two active ingredients, casirivimab and imdevimab, and was co-produced by the US manufacturer Regeneron Pharmaceuticals.

EMA endorsed it to treat people aged 12 and older.

Regkirona, made of the active ingredient regdanvimab, was endorsed for all adults.

The Amsterdam-based EMA said the safety profile of both medicines was favourable, noting only a small number of infusion-related reactions.

Pointing to studies, EMA officials said that fewer than 1 per cent of COVID-19 patients needed to be hospitalised after treatment with Ronapreve.

In a control group, 3.4 percent of patients ended up in a hospital bed.

There were 1193 patients in the study.

Regkirona is recommended to treat COVID-19 patients who do not need supplementary oxygen to breathe and face a high risk of severe infection.

The EMA cited a study of 880 patients in which only 3 percent of those treated with the drug had to be admitted to clinics while 11 per cent of patients in a control group needed to be admitted.

Until now, remdesivir has been the only drug that the agency has approved for the treatment of COVID-19.

Three more are under review.

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