Saudi Press

Saudi Arabia and the world
Tuesday, Jul 21, 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.

Newsletter

Related Articles

Saudi Press
0:00
0:00
Close
High Prices Push Coffee Drinkers Toward Whole Beans and Home Brewing
Trump Draws Boos and Podium Scrutiny at Spain’s World Cup Triumph
Spain Defeats Argentina in Extra Time to Win Second World Cup
Turkey Explores S-400 Transfer to UAE in Bid to Rejoin F-35 Program
US Retaliates Against Iran After Two American Troops Killed in Jordan
Proposed U.S.-Saudi Nuclear Pact Could Permit Limited Uranium Enrichment Under International Safeguards
Why Kentucky Fried Chicken Became KFC—and Why the False Explanations Persist
Iran Claims It Destroyed Bahrain’s Main Artificial Intelligence Center in Missile and Drone Strike
Ukrainian Drones Strike Wildberries Warehouses Deep Inside Russia
Reported CIA Mission Helped Clear the UAE’s Path to Advanced US AI Chips
Artificial Intelligence Capital Fuels Markets While Governments and Regulators Face Mounting Strategic Tests
China’s Moonshot’s Kimi K3 Narrows the Gap With Anthropic Through Scale, Openness and Lower Cost
Gold and Cash Seizure Puts Indonesia’s Senior Anti-Corruption Prosecutor Under Investigation
The Ledger Will Not Trust on Faith
Passenger Bound for Germany Refused to Sit Beside a Woman on a Plane — Then Slapped a Flight Attendant
Ukraine’s Leadership Rift Spills Into the Streets as Protesters Target Army Chief
The Ten World Cup Finals That Defined Football History
Smartphones Are Getting More Expensive, Sales Are Collapsing, and Even Apple Admits: "Prices Will Rise"
Leadership Change and Strategic Rivalry Redraw the Political Map
The AI Race Enters Its Infrastructure Era
Britain Nationalises British Steel to Protect Scunthorpe Production and Strategic Supply
Thomas Tuchel Faces Fierce Backlash After Tactical Retreat Costs England World Cup Final Berth
A Quiet Bastille Day: France Grapples with World Cup Heartbreak and Leftover Fireworks
Spain in Ecstasy: "We Feel Unbeatable, We Taught the Whole World a Lesson"
Harvard Astrophysicist to Lead U.S. Scientific Advisory on Unidentified Aerial Phenomena
Emergency Sirens Activated Across Bahrain as Interior Ministry Issues Shelter Directives
World Cup Visitors Turn American Big-Box Stores Into Souvenir Stops
Netflix Weighs Always-On Channels, Bundles and Short-Form Video
The AI Invoice Shock: Layoffs Didn't Save Managers Money — They Cost Them More
Concern: Sexually Transmitted Bacterium Among Men Develops Antibiotic Resistance
Passenger Partially Pulled Out of Ryanair Jet After Cabin Window Fails Mid-Flight
Severe Heatwave Drives Dangerous Ground-Level Ozone Pollution Across Two Thirds of European Union
The Physical and Electronic Barriers Disrupting Domestic Wireless Networks
France and Morocco Open World Cup Quarter-Finals as Collina Defends Refereeing
Tech Pulse: The Future of AI and Screen Culture
Global News Briefing: Escalating Geopolitical Tensions and Corporate Shakeups
Global News Brief: Escalating Conflicts, Public Health Crises, and World Cup Drama
Europe's Growing Struggle with Extreme Heat and Air Conditioning
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
Japanese Technology Firm Fujitsu Launches Advanced Artificial Intelligence Tool for Corporate Disclosures
South Africa Officially Launches Nationwide Campaign for Highly Contested Local Government Elections
United Kingdom Commits Additional Funding for Unexploded Ordnance Clearance in Laos
Singapore Announces Stringent New Greenhouse Gas Regulations for Commercial Cooling Systems
Cambodia and Thailand Hold High-Level Border Security Talks at United Nations Headquarters
Myanmar Military Government and China Sign Major Agreement to Upgrade Media and Cultural Cooperation
Knife Attack at Swiss Train Station Leaves Three Injured in Suspected Act of Domestic Terrorism
Transnational Extortion Gang Threatens Canadian Police With Army of One Thousand Armed Operatives
×