Monoclonal antibodies: EMA approval for two coronavirus treatments in the coming days

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The European regulatory authority is preparing to approve the use of two monoclonal antibodies to address it coronavirus In the coming days, two European sources told Reuters, as the European Union faces a new pandemic resurgence – cases and hospitalizations are rising in a number of countries, despite the high level of vaccination in many of them.

More specifically, the European Medicines Agency (EMA) is expected to approve within a week the treatment developed by the American biotechnology company Regeneron and the Swiss Roche, according to the international news agency.

The antibody cocktail is known in the US as REGEN-COV, while it is available elsewhere under the brand name Ronapreve.

It will also be approved this week for intra-EU use of Regkirona monoclonal antibody, developed by the South Korean biotechnology company. Celltrion, added the same sources, asking not to be named because the information is confidential.

The date has not been decided

Another European source stated that the two approvals “are imminent“, But the exact date has not yet been decided, as broadcast by APE BPE.

Both formulations are used in patients who are at risk of developing serious illness.

Applications for approval were submitted on 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 in late November, according to a company representative.

Roche, which has applied for Ronapreve approval, not responded to a request for comment on the information.

The EMA denied to comment on the information, but announced that the two formulations will be discussed during the monthly meetings of the committee responsible for approvals, which started yesterday, Monday, and will last until Thursday.

It is worth mentioning that the company 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.

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