The European regulator is preparing to approve the use of two monoclonal antibodies to treat Covid-19 in the coming days, two European sources told Reuters, as the European Union faces a new resurgence of the epidemic with rising cases and hospitalizations, despite high level of vaccination in many European countries.
This will be the first time that the European Medicines Agency (EMA) has approved such treatments.
The EMA is expected to approve within a week the treatment developed by the American biotechnology company Regeneron and the Swiss Roche, a European source said. The antibody cocktail is known in the US as REGEN-COV, while it is available elsewhere under the brand name Ronapreve.
The European Medicines Agency will also approve this week for use within the European Union of Regkirona monoclonal antibody, developed by South Korean biotechnology company Celltrion, the source added, asking not to be named because the information is confidential.
A second European source said the two approvals were “imminent”, but the exact date has not yet been decided.
Both formulations are used in patients who are at risk of developing a serious illness.
Applications for approval were submitted in early October and the EMA had then announced that it would “issue an assessment in two months”.
Celltrion is awaiting a decision from the European regulator at the end of November, according to a company spokesman.
Roche, which has applied for Ronapreve approval, did not respond to a request for comment.
The EMA declined to comment on the information, but said the two formulations would be discussed during the monthly meetings of the approval committee, which began yesterday, Monday, and will last until Thursday.
Eli Lilly last week withdrew its application for approval of its own antibody treatment by the European regulator, citing a lack of interest from EU member states as the Union turns to other suppliers.
.
