London Daily

Focus on the big picture.
Wednesday, Jul 08, 2026

European Union To Approve First Covid Antibody Drugs Amid Spike In Cases

European Union To Approve First Covid Antibody Drugs Amid Spike In Cases

The European Union drugs regulator is set to authorise the use of two monoclonal antibodies to treat COVID-19 this week, to treatments developed by US biotech firm Regeneron and Swiss giant Roche, one source said

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 US 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.

FULL APPROVAL


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.

Comments

Oh ya 5 year ago
From the few true news sources they say the flood of people do not have Covid that are filling hospitals they have other problems. It's called ADE. Buckle up as winter sets in it will explode in cases

Newsletter

Related Articles

0:00
0:00
Close
Rare Early Copy of US Declaration of Independence Found in British Archive
Cornish Language Revival Gains Momentum Through Schools and Community Programs
UK Authorities Face Criticism Over Prisoner Early Release Safeguards
Clacton By-Election Set After Nigel Farage Resigns Seat to Trigger Contest
Government Agencies Review Long-Term Fiscal Risks from Aging Population and Low Productivity
UK Heatwaves Expose Pressure on Public Transport and Housing Infrastructure
UK Government Prepares Welfare Review Amid Debate Over Personal Independence Payment Reform
UK Government Expands Rapid Endometriosis Testing Across NHS Services
Vistry Group Issues Profit Warning as UK Housing Market Faces Continued Pressure
Virgin Media Receives Record Twenty-Eight Million Pound Fine Over Contract Cancellation Failures
Office for Budget Responsibility Warns UK Public Finances Face Long-Term Pressure
UK Watchdog Warns Regional Income Gap Has Barely Narrowed in Three Decades
IMF Raises United Kingdom Growth Forecast as Inflation and Energy Pressures Ease
UK Government Launches Regulatory Reform Bill to Speed Up Commercialization of Innovation
Prince Harry Loses Privacy Lawsuit Against Daily Mail Publisher After High Court Rejects Claims
Federal Financial Framework Shifts as Treasury Launches Universal Savings Program for Minors
Jet2 Reports Strong Summer Travel Demand as Bookings Rise Seven Percent
Prince Harry Loses High Court Privacy Case Against Daily Mail Publisher
British Universities Warn Against Potential European Union Tuition Fee Changes
Heal Fertility Clinic Investigated After Embryo Biopsy Sample Mix-Up
Resolution Foundation Warns Regional Income Divide Has Barely Improved Since 1997
British Markets Remain Cautious as Middle East Tensions Rise and Government Transition Nears
Andy Burnham Poised to Become United Kingdom Prime Minister in Expected Political Transition
Nigel Farage Resigns as Member of Parliament Ahead of By-Election Amid Funding Investigation
Trump Declares Iran Ceasefire Over After Renewed Attacks on United States Bases
French Court Allows Le Pen to Run for Presidency, but with an Electronic Tag: "I Will Appeal, and I Will Run"
$1.4 Trillion: The Lawsuit That Could Crush Meta
Europe's Growing Struggle with Extreme Heat and Air Conditioning
UK Daily Briefing: Legal Developments and Social Issues
Political Turmoil and Rising Costs
Anthropic Reengineers Agentic Architecture to Shift Autonomous Workplace Automation to the Cloud
Logic Flaw in Windows 11 Permission Architecture Silently Consumes Hundreds of Gigabytes of Local Storage
Apple Advances Late-Stage Operating Systems with Fourth Beta Deployments
Global Crisis Alert: Escalating Middle East Tensions and UK Political Upheaval
UK Parliament Pushes for Greater Domestic Control Over Critical Technologies
UK Parliament Warns Trade Fair and Exhibition Industry Is Losing Global Competitiveness
Police Launch Murder Investigation After Mother and Two Children Found Dead Near Bedford
British Chambers of Commerce Survey Shows Business Confidence Falls to Post-Pandemic Low
UK Parliament Report Warns Britain Risks Falling Behind in Artificial Intelligence Sovereignty
Office for Budget Responsibility Warns United Kingdom Faces Long-Term Fiscal Pressures
Nigel Farage Resigns as Member of Parliament Amid Financial Scrutiny and Triggers By-Election
Deep Purple Has Released Its Best Album in Decades
UK MPs Criticise Student Loan System as Potentially Mis-Sold to Millions of Borrowers
Policy Groups Propose Bank of England-Backed Solar Loan Scheme for Millions of Homes
UK Health Agency Issues Amber Heat Alerts Across Six Regions as Temperatures Rise
Royal Air Force F-35 Jets Conduct First High North Air Policing Missions From Aircraft Carrier
Major UK Companies Join Government Cybersecurity Pledge Amid Rising Digital Threats
UK Sanctions Russian Operatives Linked to Chemical Weapons Programmes and Poisoning Cases
UK Government Expands Free Breakfast Clubs and Limits School Uniform Costs
UK Water Companies Face Tougher Penalties Under New Environmental Enforcement Rules
×