Antibodies against COVID-19 prior to EU approval

12 Nov 2021

Antibodies against COVID-19 prior to EU approval

The European Medicines Agency (EMA) has paved the way for approval of two antibody therapies for the treatment of COVID-19.

One is Ronapreve from the Swiss pharmaceutical company Roche and the US company Regeneron, and the other is Regkirona (Regdanvimab) from the manufacturer Celltrion in South Korea. The two antibody drugs are to be used in the early stages of infection. According to the EMA recommendations, It is the group of older, immunocompromised sufferers who benefit most from "passive vaccination," in which antibodies are administered directly. While Regkirona targets adults, Ronapreve can be given to people aged 12 and older.

The EMA's experts had reviewed and evaluated all of the manufacturers' data. Following the positive recommendation, the EU Commission must make the final decision. This is considered a formality. So far, only one drug for the treatment of COVID-19 patients has been approved in the EU.

The approval is an "important step," said EU Health Commissioner Stella Kyriakides. Given the increase in corona infections in almost all member states, she said it is "reassuring that many promising therapies are in development as part of our treatment strategy for COVID-19." The goal is to have up to five new therapies approved in the EU by the end of the year.