London Daily

Focus on the big picture.
Saturday, Jul 18, 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
For 36 Years, He Scammed About 300 Luxury Hotels — Until He Was Caught
England's World Cup Exit Expected to Cost Hospitality and Retail £334 Million
Former ICC Prosecutor Aide Speaks Publicly About Allegations Against Karim Khan
Opposition Raises Questions Over June Heatwave Power Grid Pressures
Mastercard Explores Sale of Majority Stake in UK Payments Operator Vocalink
Boeing Forecasts Global Commercial Aircraft Fleet Will Double by 2045
London GP Surgeries Receive £18 Million to Expand Primary Care Capacity
Health Advisers Recommend Nationwide Meningitis B Vaccination for Teenagers
OECD Warns UK Economy Faces Slower Growth and Weak Productivity
Treasury Places Major Global Cloud Providers Under Direct Financial Oversight
Financial Markets Rally as Shabana Mahmood Emerges as Leading Treasury Candidate
Incoming Government Prepares Thames Water Nationalisation and New North Sea Drilling Approvals
UK Government Plans Deep Cuts to Bilateral Aid for African Nations
United States and Iran Exchange Direct Strikes for Seventh Consecutive Night
Incoming Prime Minister Andy Burnham Confirmed as Labour Leader Ahead of Downing Street Handover
Britain Nationalises British Steel to Protect Scunthorpe Production and Strategic Supply
Andy Burnham Takes Labour Leadership and Prepares to Become Britain’s Seventh Prime Minister in a Decade
Tech Companies Want to Move Computing Off Your Screen and Onto Your Body
White House Teleprompter Operator Earned More Than $100,000 From Bets Linked to the President's Speeches
French Prime Minister Survives No-Confidence Vote After Controversial Budget Cuts
European Commission Opens Excessive Deficit Procedure Against France
French Senate Blocks Key Immigration Reform Measures
French Government Pushes EU Action Against Ultra-Fast Fashion Imports
French Parliament Debates Expanded Autonomy Powers for Corsica
France Reopens Autonomy Talks With New Caledonia After Months of Unrest
Bordeaux Wine Producers Seek Three Hundred Million Euro Aid Package After Export Collapse
French Farmers Block Spain Border Crossings Over Imported Food Competition
Cannes Film Festival Bans Fully Artificial Intelligence-Generated Films From Competition
TotalEnergies Shifts More Than Three Billion Euros of Green Investment From Europe to the United States
LVMH Chief Executive Bernard Arnault Presents Succession Plan for Luxury Empire
Kering Reports Fifteen Percent Revenue Drop as Chinese Luxury Demand Weakens
Sanofi Reports Positive Results From Messenger RNA Respiratory Vaccine Trials
France Places Energy Price Caps Under Review to Protect Households Through Winter
EDF Connects Two New Nuclear Reactors to France’s Electricity Grid
Mistral Secures European Commission Contract for Sovereign Artificial Intelligence Models
Renault Opens Next-Generation Electric Battery Plant in Northern France
Air France Signs Two Billion Euro Sustainable Aviation Fuel Deal to Cut Emissions
Marseille Launches Three Billion Euro Port Expansion to Strengthen Mediterranean Trade Role
French-Owned Ubisoft Announces Global Restructuring With Nearly One Thousand Job Cuts
National Railway Operator Suspends Artificial Intelligence Ticket Pricing System After Consumer Backlash
United Kingdom to Ban Sales of High-Caffeine Energy Drinks to Under-Sixteens
Home Office Designates Iranian and Russian Paramilitary Groups as National Security Threats
National Health Service Launches Housing Plan to Retain London Healthcare Workers
British Heatwave Fuels Wildfires and Emergency Evacuations in Scotland
United Kingdom and Estonia Sign Defence Agreement to Strengthen NATO’s Eastern Flank
United Kingdom Cuts Bilateral Aid to African Nations by More Than Eighty Percent
Bank of England Overhauls Banking Rules to Encourage More Lending to Businesses
United Kingdom and India Free Trade Agreement Enters Into Force, Reshaping Bilateral Economic Ties
Andy Burnham Confirmed as New Labour Leader and Prime Minister-Designate
UK Government Faces Pressure Over Extreme Heat Workplace Rules
×