The European Medicines Agency (EMA) has recommended the authorization of two medicines for the treatment of COVID-19.
The two medicines are Ronapreve made by the Switzerland-based pharmaceutical company Roche, and Regkirona made by South Korean drug company Celltrion, the agency said in a statement on Thursday.
The EMA said that Ronapreve can be used for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
Ronapreve can also be used for preventing COVID-19 in people aged 12 and older weighing at least 40 kilograms, it said.
The EMA said Regkirona can be used for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe.
The EMA said it will send its recommendations for both medicines to the European Commission for rapid legally binding decisions.
Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the EMA, joining the list of COVID-19 products that have received a positive opinion since remdesivir made by US drug company Gilead was recommended for authorization in June 2020, said the EMA statement.
The EMA said studies show that treatment with Ronapreve or Regkirona significantly reduces hospitalization and deaths in COVID-19 patients at risk of severe COVID-19. Another study showed that Ronapreve reduces the chance of having COVID-19 if a household member is infected with SARS-CoV-2, the virus that causes COVID-19.
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