Beautiful Virgin Islands

Friday, Sep 11, 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

Beautiful Virgin Islands
0:00
0:00
Close
Merz Rebukes AfD Expansion in Saxony-Anhalt
OpenAI Unveils GPT-6 and Says: "We May Already Have Reached AGI"
Congressman Accused Andrew of Sex Crimes in the United States
Donald Trump: "I'm Glad Harry and Meghan Left the United States"
Spicy Food Is Linked to Lower Death Risk — but It Is Not a Miracle Cure
AfD Enters Saxony-Anhalt Election at 41% in Historic Test for German Politics
Gen Z Turns to Investing as America's First-Home Dream Moves Further Out of Reach
TSA Unveils Major Airport-Security Overhaul as It Drops Gold+ Privatization Plan
CIA Chief Warned Russia Against Attacking NATO in Secret Moscow Mission
Raheem Sterling Charged With Dangerous Driving After Lamborghini Crash
The Secret Dolly Parton Kept Until Her Death: "She Was Much Sicker Than She Let On"
Glacier Collapse, Not Earthquake, Triggered Deadly Nepal-Tibet Flood
Turnbull Warns AUKUS Could Leave Australia Without Promised Nuclear Submarines
California Billionaires Pour More Than $150 Million Into Fight Over Proposed Wealth Tax
German Broadcaster Goes Dark to Warn AfD Could End Its Saxony-Anhalt Service
Badenoch Plans Major Shadow Cabinet Reshuffle as Tories Struggle in Third Place
Prime Minister Andy Burnham to Give Ukraine Classified Storm Shadow Blueprints for Domestic Missile Production
UK Graduate Job Vacancies Plunge 45% to Lowest Levels on Record
Iranian Hackers Shut Down British Power Plant for Four Days in Landmark Cyber Attack
Novak Djokovic Reveals Relentless Self-Doubt and Rejects Retirement in New Documentary
Trump Imposes 50% Tariffs on Canadian Goods After Bilateral Trade Talks Collapse
Australia Combines Indigenous Fire Knowledge With Satellite Tech to Combat Catastrophic Wildfires
Father and Son Jailed in Scotland Over £900,000 Airport Cannabis Smuggling Operation
UK Fraud Reports Surge Sevenfold as Criminals Exploit QR Codes in Parking Meters and Phishing Emails
Brighton Thrash Aston Villa in Four-Goal Opening Half as Manchester City Trail Bournemouth
Erin Patterson Appeals Triple Murder Convictions After Hotel Mixed Sequestered Jury With Prosecution
The rise and fall of Hui Ka Yan, China’s richest man
Woke: Britain Considers Plain Packaging for Cigars as Specialist Shops Warn of Industry Collapse
Britain's Public-Service Productivity Remains Below 2019 as £80 Billion Output Gap Fuels WFH Debate
Mandelson Epstein Case in Jeopardy as U.S. Files Stay Out of Reach
Prince Harry and Six Others Ordered to Pay £9.5 Million After High Court Defeat
Petrol Bombs Set Luxury Cars Alight Outside Birmingham Wedding as Police Hunt Three Men
Bitcoin Surges Toward $80,000 as Short Squeeze and ETF Inflows Ignite Crypto Rally
Twenty-Nine US States Take Meta to Trial Over Alleged Child Addiction on Instagram and Facebook
Former Scottish National Party Executive Peter Murrell Jailed for Five Years Over £400,000 Embezzlement
Moderna and Merck's Personalized Cancer Vaccine Succeeds in Historic Late-Stage Melanoma Trial
Prince Harry and Meghan to Move Back to Britain With Their Children
England and Wales Have Fewer Than 1,800 Prison Places Left for Men
Suspected People Smuggler Arrested After Investigation Identified Him
Children's Doctors Warn That Vaping Can Lead Young People to Smoking
Hundreds of Thousands of Students Receive GCSE and Vocational Results Across England, Wales and Northern Ireland
Here Is What Can Never Happen in Your Country: Taiwan Is Giving Money to All Its People Because It Collected Too Much Tax
UK Inflation Rises to 2.9% as Energy Bills Jump
UK Issues New Conduct Guide for Asylum Seekers on Consent and Respect
A Sleepless Night on Wall Street: Nasdaq to Begin Nearly Round-the-Clock Trading
"The First in the World": 69-Year-Old Protested Artificial Intelligence—and Went to Jail
Ukraine's Ousted Defence Minister Calls for Wartime Presidential Election
China’s Lifelike AI Humans Move From Livestreams Into Real-World Service Roles
Sarah Ferguson Reportedly Retreats to Late Ex-Boyfriend's Swiss Chalet
Cristiano Ronaldo and Georgina Rodríguez Sign Prenup Protecting Their Separate Fortunes
×