The European Medicines Agency (EMA) announced on Monday that it has launched an evaluation procedure to issue a marketing authorization for an antibody cocktail developed by Regeneron and Roche to treat and prevent COVID-19 disease in the elderly. for over 12 years, informs Reuters.
The European Medicines Agency has said it will look into the risks and benefits of the drug, called Ronapreve, and could take a look at it in the next two months. The EMA has already started the procedure for evaluating the new treatment.
Ronapreve has received emergency authorization to treat COVID-19 in more than 20 countries, including the United Kingdom and the United States. Ronapreve is part of a class of medicines called monoclonal antibodies, which mimic the natural antibodies synthesized by the human body to fight infections.
EMA officials said they are looking at clinical data on the effectiveness of the drug in preventing outpatients for outpatients, as well as other studies looking at the effectiveness of preventing COVID-19 in adults and children at risk of being infected by a family member who has already been infected with the new coronavirus.
Remdesivir, an antiviral created by Gilead, is the only anti-COVID-19 treatment that has been approved for use in the European Union, according to Agerpres.ro.
Applications for authorization have been made for other anti-COVID-19 treatments, including the drug Olumiant produced by Eli Lilly against rheumatoid arthritis, Kineret produced by Sobi, Regdanvimab produced by Celltrion and Tocilizumab, an anti-arthritis drug marketed by Roche under the trade name RoActemra.