The response is expected within two months, said the EMA on Monday.
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It is a decisive stage which has just begun. The European Medicines Agency (EMA) began Monday October 11 to study the sale of the Ronapreve treatment (in English). This treatment, developed by the American biotech Regeneron, in partnership with the Roche laboratory, combines two monoclonal antibodies (casirivimab and imdevimab) directed specifically against the S protein (spike or spicule) of Sars-CoV-2. They work by preventing the virus from entering cells, thus fighting against its replication.
This combination was recommended by the WHO at the end of September and authorized in France at the beginning of August by the Haute Autorité de santé (HAS). A temporary five-month authorization was granted by the HAS, which relied on a scientific opinion from the National Medicines Safety Agency (ANSM), which assesses the benefit-risk ratio of medicines.