par Francesco Guarascio
BRUSSELS (Reuters) – The European Medicines Agency (EMA) is preparing to authorize the use of two anti-COVID-19 monoclonal antibody treatments in the coming days, two sources in the European Union said, which would be a first in the EU for this type of therapy.
Despite high vaccination rates in many Member States, the European Union (EU) is facing a new wave of infections and hospitalizations.
The regulator of the Twenty-Seven will this week give the green light to the treatment jointly developed by the American laboratory Regeneron and the Swiss giant Roche, said a source, a cocktail of antibodies known in the United States as REGEN-COV and sold elsewhere as Ronapreve.
According to the same source, who asked not to be identified for confidentiality reasons, the AEM will also authorize the use in the EU of Regkirona, a monoclonal antibody treatment designed by the South Korean biotech company. Celltrion.
A second official familiar with the process said approvals were “imminent” but specific dates had not yet been set. Applications for approval of the two drugs were submitted in early October. The MEA then indicated “that it could issue an opinion within two months”.
Celltrion expects a decision by the end of November, a company spokesperson said. Roche did not respond to a request for comment.
The European regulator refused to speak, but clarified that the two drugs were the subject of discussions during the monthly meetings this week of the committee of the agency responsible for authorizations of treatments.
These started on Monday and will continue until Thursday.
The ongoing review comes after Eli Lilly last week withdrew its request for EU approval of its antibody treatment, with the pharmaceutical group citing too weak demand from member states in the face of others suppliers.
The EU has vaccinated more than 75% of its adult population, but in some countries in the bloc the rate is below 40%.
(With the contribution of Cha Sangmi in Seoul, French version Juliette Portala)
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