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South Korean COVID-19 drug undergoes European review

25.02.2021 85 просмотров

The European regulator has begun an examination of a South Korean drug for coronavirus.


The European Medicines Agency (EMA) has begun a gradual evaluation of the drug Regdanvimab (“Regdanvimab”), developed by the South Korean company Celltrion (“Seltrion”), for the treatment of coronavirus. This is stated in the regulator's press release circulated in environment.


, - the message says.


At this stage, the EMA has not obtained all the necessary data and cannot conclude whether the benefits outweigh the risks of its use. However, the agency has begun evaluating and collecting additional information until sufficient data is obtained to recommend an interim marketing authorization.


According to Celltrion, the drug can be used to treat people over 60 years old with mild coronavirus infection and other serious diseases (diabetes, heart disease, hypertension, chronic diseases of the respiratory system), as well as for the treatment of adults with a moderate severity of the disease. The drug is an intravenous injection.


In January, the company published the results of a study on the efficacy and safety of its drug in 327 patients. CT-P59 was found to reduce by 54% the number of patients with COVID-19 who develop severe cases requiring hospital treatment. The drug also shortens the recovery time of patients. Celltrion plans to conduct the third phase of clinical trials involving 1,172 people in 10 countries around the world.


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