Amsterdam, November 11 (BNA): Two antibody therapy drugs to combat COVID-19 have been approved by the European Medicines Agency (EMA), the authority announced on Thursday.
The EMA recommends licensing Ronapreve from Swiss drugmaker Roche and Regkirona from Celltrion in South Korea. And the German news agency (dpa) said that both are recommended for use in the early stages of infection.
The European Commission must bless before the two drugs reach the EU single market, but this is a formality.
Ronapreve consists of two active ingredients, casirivimab and imdevimab, and was produced jointly by the US company Regeneron Pharmaceuticals. EMA endorsed it to treat people aged 12 and over.
Regkirona, which is made with the active ingredient regdanvimab, is approved for all adults.
The Amsterdam-based European Medicines Agency said the safety profile for both drugs was favourable, citing only a few infusion-related interactions.
Referring to the studies, EMA officials said less than 1 percent of Covid-19 patients required hospitalization after treatment with Ronapreve. In the control group, 3.4 percent of patients ended up in a hospital bed. There were 1,193 patients in the study.
Regkirona is recommended to treat Covid-19 patients who do not need additional oxygen to breathe and are at high risk of severe infection.
The EMA cited a study of 880 patients in which only 3 percent of those treated with the drug were admitted to clinics, while 11 percent of patients in the control group needed to be admitted.
So far, remdesivir has been the only drug approved by the agency to treat COVID-19. Three others are under review.
European Health Commissioner Stella Kyriakides welcomed the move. “With COVID-19 infections on the rise in nearly all member states, it is reassuring to see many promising treatments under development,” she said in a written statement.
“While the EU has one of the highest vaccination rates in the world, people will still get sick and need safe and effective treatments to fight infection and improve not only the odds of recovery, but also survival,” Kyriakides continued.
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