The European Medicines Agency will give a green signal to antibody treatment this week. (file)
Brussels:
EU drug regulators are set to authorize the use of two monoclonal antibodies to treat COVID-19 patients in the coming days, two EU sources told Reuters, in its first approval of such treatments.
The bloc could face a new surge in infections and hospitalizations, despite high levels of vaccination in many countries.
A source said the European Medicines Agency (EMA) will give the green signal this week to a treatment developed by US biotech firm Regeneron and Swiss giant Roche. The cocktail of antibodies is known as REGEN-COV in the United States, and is sold elsewhere under the brand name Ronaprev.
The European regulator will also this week authorize use in the European Union of the monoclonal antibody regkirona developed by South Korean biotech company Celltrion, the source said, asking not to be named because the information is still confidential.
A second official familiar with the authorization process said approvals were “imminent”, but exact dates had not been set.
Both drugs are currently used to treat COVID-19 patients at risk of developing a serious infection.
The two authorities will mark the agency’s expediting of drug approvals.
Applications for both drugs were submitted in early October and the EMA said it “may issue an opinion within two months”. Celtrion expects a decision by the end of November, a spokesperson for the company said.
Roche, who applied for Ronaprev’s approval in Europe, did not respond to a request for comment.
The EMA declined to comment on the approval, but said the two drugs were being discussed this week at monthly meetings of the agency’s committee responsible for authorizing treatments. The meeting began on Monday and will continue till Thursday.
Following a review, 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.
full approval
Gilead’s antiviral remdesivir is the only treatment against COVID-19 approved by the EMA since the start of the pandemic.
Regeneron’s antibody cocktail was granted emergency authorization in the United States last year, and received conditional marketing authorization in the UK in August.
The drug is being evaluated by the EMA as part of a lengthy process that would result in a full marketing authorisation, the sources said, with a note that so far there was no immediate medical need to use an accelerated process.
The European Union has immunized more than 75% of its adult population, although some of the 27 countries have less than 40%.
The EMA issued recommendations to national authorities in the first quarter of this year on how to use both drugs before they are fully approved, paving the way for their use in several European countries.
The marketing authorization would allow the use of drugs where national agencies had not yet approved them and would reduce the legal risk to 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.
A European Commission spokesman said in June that the EU had achieved about 55,000 courses of therapy.
Block has no supply deal with Celltrion, whose antibody treatment has so far been approved only in South Korea.
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)
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