Saudi Press

Saudi Arabia and the world
Thursday, Mar 19, 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
U.S. Lawmakers Press Rubio to Enforce Strong Safeguards in Saudi Nuclear Deal
Iran Issues Evacuation Warning to Gulf States After Strike on Major Gas Field
Saudi Arabia to Convene Arab and Islamic Ministers for Urgent Talks on Regional Conflict
Saudi Arabia Confirms Eid al-Fitr as Moon Sighting Determines End of Ramadan
Saudi Arabia Boosts Crude Exports to Highest Levels Since 2023, Data Shows
Iran Issues Warning to Gulf Energy Infrastructure Following Strike on Major Gas Field
Saudi Arabia Restarts Ras Tanura Refinery Following Drone Strike, Reinforcing Energy Resilience
Saudi Arabia Restarts Ras Tanura Refinery Following Drone Strike, Reinforcing Energy Resilience
Saudi Arabia Intercepts Ballistic Missiles Targeting Riyadh Amid Escalating Regional Tensions
Saudi Arabia Restores Significant Oil Flows Using Hormuz Bypass Amid Regional Tensions
Saudi Arabia Signals Potential Activation of Defence Pact with Pakistan Amid Escalating Iran Conflict
Saudi Supreme Court Urges Muslims to Observe Crescent Moon for Eid Determination
Saudi Supreme Court Urges Muslims to Observe Crescent Moon for Eid Determination
Saudi Arabia Reassesses Iran Strategy as Regional Conflict Tests MBS’s Diplomatic Bet
Iran Steps Up Drone Strikes on Saudi Oil Sites, Heightening Risks to Global Supply
Regional Fallout Grows as Iran Conflict Sends Shockwaves Across Jordan, Saudi Arabia, and Egypt
Saudi Arabia Intercepts Seven Drones in Intensifying Regional Security Threat
Saudi Arabia Intercepts Seven Drones in Intensifying Regional Security Threat
Saudi Arabia Weighs Regional Risks as Iran Conflict Deepens and Security Calculations Shift
Gulf States Confront Limits of U.S. Protection as Regional War Intensifies
Gulf Producers Rush to Reroute Oil Exports as Iran Tightens Control of Hormuz Strait
Saudi Gaming Investment Arm Acquires Strategic Stake in Capcom to Expand Global Influence
Iran Intensifies Strikes on Saudi Oil Infrastructure as Regional War Escalates
Saudi Arabia Targets South African Professionals in New Recruitment Drive Amid Regional Uncertainty
Formula One Faces Major Financial Hit as Bahrain and Saudi Arabian Grands Prix Cancelled Amid Middle East Conflict
U.S. and Saudi Firms Launch Local Production of Attritable Drone Systems in Saudi Arabia
Saudi Arabia and UAE Warn Rising Gulf Tensions Could Endanger Regional Security
Saudi Arabia Rejects Claims It Encouraged Prolonged War With Iran
Saudi Arabia to Host World’s Largest Single-Cell Protein Plant as Food Security Push Accelerates
Saudi Crown Prince Urges Trump to Continue Military Pressure on Iran
Iran Intensifies Drone Campaign Against Saudi Arabia as Gulf Conflict Escalates
When Is Eid al-Fitr 2026? Saudi Arabia Awaits Moon Sighting to Confirm End of Ramadan
When Is Eid al-Fitr 2026? Saudi Arabia Awaits Moon Sighting to Confirm End of Ramadan
Iranian Missile Strike Damages Five U.S. Refueling Aircraft at Saudi Air Base
Iranian Missile Strike Damages Five U.S. Refueling Aircraft at Saudi Air Base
Washington State Pilot Among Six U.S. Airmen Killed in Military Aircraft Crash Over Iraq
Severe Storm Threat Looms Over Washington as Tornado Risk and Damaging Winds Target Mid-Atlantic
Trump Supports FCC Warning to Broadcasters Over Iran War Reporting
Trump Supports FCC Warning to Broadcasters Over Iran War Reporting
Saudi Stocks Edge Lower as Tadawul All Share Index Slips Slightly at Market Close
Iranian Missile and Drone Strike Targets Saudi Arabia’s Prince Sultan Air Base Hosting US Aircraft
Saudi Air Defenses Intercept Drone Over Eastern Province as Iranian Strike Campaign Intensifies
Middle East War Reshapes Gulf Economies as Saudi Arabia and Oman Gain Strategic Leverage While UAE Faces Economic Shock
Iranian Ambassador in Riyadh Blames ‘Enemies’ for Attacks Across the Gulf
Israeli Envoy Ron Dermer Reportedly Visits Saudi Arabia for Discussions on Potential Lebanon Talks
Formula One Cancels Bahrain and Saudi Arabian Grands Prix Scheduled for April
Iran’s Ambassador in Riyadh Rejects Claims Tehran Targeted Saudi Oil Facilities
Saudi Arabia Declares 2026 ‘Year of Artificial Intelligence’ in Major Push for Data-Driven Economy
Saudi Arabia’s 2018 Budget Signals Strong Push for Non-Oil Economic Growth
Pakistan Envoy in Riyadh Says Regional Diplomacy Intensifying to Prevent Wider Middle East War
×