* EMA to approve Regeneron-Roche cocktail of monoclonal
* EU agency to authorise also Celltrion's antibody therapy
* Full marketing authorisations expected this week - source
BRUSSELS, Nov 9 (Reuters) - The European Union drugs
regulator is set to authorise the use of two monoclonal
antibodies to treat COVID-19 patients in coming days, two EU
sources told Reuters, in its first approvals of such therapies.
The authorisations would come as the bloc faces a new surge
in infections and hospitalisations despite high vaccination
levels in many countries.
The European Medicines Agency (EMA) will this week give the
green light to the treatment developed by U.S. biotech firm
Regeneron and Swiss giant Roche, one source
said. The cocktail of antibodies is known as REGEN-COV in the
United States, and is sold elsewhere under the brand name
The European regulator will also authorise this week the use
in the EU of the monoclonal antibody Regkirona, developed by
South Korean biotech company Celltrion, the source
added, asking not to be named because the information is still
A second official familiar with the authorisation process
said the approvals were "imminent" but the precise dates had not
Both drugs are currently used to treat COVID-19 patients at
risk of developing a severe infection.
The two authorisations would mark an acceleration in the
agency's drug approvals.
Applications for both drugs were submitted in early October
and EMA said then "it could issue an opinion within two months".
Celltrion expects a decision by the end of November, a
spokesperson for the company said.
Roche, who applied in Europe for the approval of Ronapreve,
did not respond to a request for comment.
EMA declined to comment on the approvals but said the two
drugs were being discussed at this week's monthly meetings of
the agency's committee that is responsible for authorisations of
treatments. The meetings started on Monday and will continue
The review comes after Eli Lilly last week withdrew
its application for EU approval of its antibody-based treatment,
citing a lack of demand from EU member states as the bloc
focuses on other suppliers.
(Reporting by Francesco Guarascio @fraguarascio; additional
reporting by Cha Sangmi in Seoul; Editing by Nick Macfie)