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 By Francesco Guarascio
BRUSSELS (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 Ronapreve.
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 confidential.
A second official familiar with the authorisation process said the
approvals were "imminent" but the precise dates had not been
decided.
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 until Thursday.
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.
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The only treatment against COVID-19 approved by
EMA since the start of the pandemic is Gilead's
antiviral remdesivir.
Regeneron's antibody cocktail was granted
emergency authorisation in the United States
last year, and in August received conditional
marketing authorisation in Britain.
The drug is being assessed by EMA under a longer
procedure, which will result in a full marketing
authorisation, the sources said, with one noting
that so far there had not been an urgent medical
need to use a speedier procedure.
The EU has immunised over 75% of its adult
population, although in some nations of the
27-country bloc the uptake is below 40%.
EMA issued recommendations to national
authorities in the first quarter of this year on
how to use both drugs before they were fully
approved, paving the way for their use in
several European countries.
The marketing authorisation will allow the use
of the drugs where national agencies had not yet
approved them and would reduce legal risks for
governments in countries that are already
administering them.
Last week Regeneron reported
higher-than-expected quarterly revenue on strong
demand for its antibody cocktail in the United
States.
The EU has secured about 55,000 courses of the
therapy, a European Commission spokesperson said
in June.
The bloc has no supply deal with Celltrion,
whose antibody treatment has so far been
approved only in South Korea.
(Reporting by Francesco Guarascio @fraguarascio;
additional reporting by Cha Sangmi in Seoul;
Editing by Nick Macfie)
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