Saudi Press

Saudi Arabia and the world
Tuesday, Nov 25, 2025

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
Families Accuse OpenAI of Enabling ‘AI-Driven Delusions’ After Multiple Suicides
Riyadh Metro Records Over One Hundred Million Journeys as Saudi Capital Accelerates Transit Era
Trump’s Grand Saudi Welcome Highlights U.S.–Riyadh Pivot as Israel Watches Warily
U.S. Set to Sell F-35 Jets to Saudi Arabia in Major Strategic Shift
Saudi Arabia Doubles Down on U.S. Partnership in Strategic Move
Saudi Arabia Charts Tech and Nuclear Leap Under Crown Prince’s U.S. Visit
Trump Elevates Saudi Arabia to Major Non-NATO Ally Amid Defense Deal
Trump Elevates Saudi Arabia to Major Non-NATO Ally as MBS Visit Yields Deepened Ties
Iran Appeals to Saudi Arabia to Mediate Restart of U.S. Nuclear Talks
Musk, Barra and Ford Join Trump in Lavish White House Dinner for Saudi Crown Prince
Lawmaker Seeks Declassification of ‘Shocking’ 2019 Call Between Trump and Saudi Crown Prince
US and Saudi Arabia Forge Strategic Defence Pact Featuring F-35 Sale and $1 Trillion Investment Pledge
Saudi Sovereign Wealth Fund Emerges as Key Contender in Warner Bros. Discovery Sale
Trump Secures Sweeping U.S.–Saudi Agreements on Jets, Technology and Massive Investment
Detroit CEOs Join White House Dinner as U.S.–Saudi Auto Deal Accelerates
Netanyahu Secures U.S. Assurance That Israel’s Qualitative Military Edge Will Remain Despite Saudi F-35 Deal
Ronaldo Joins Trump and Saudi Crown Prince’s Gala Amid U.S.–Gulf Tech and Investment Surge
U.S.–Saudi Investment Forum Sees U.S. Corporate Titans and Saudi Royalty Forge Billion-Dollar Ties
Elon Musk’s xAI to Deploy 500-Megawatt Saudi Data Centre with State-backed Partner HUMAIN
U.S. Clears Export of Advanced AI Chips to Saudi Arabia and UAE Amid Strategic Tech Partnership
xAI Selects Saudi Data-Centre as First Customer of Nvidia-Backed Humain Project
A Decade of Innovation Stagnation at Apple: The Cook Era Critique
President Trump Hosts Saudi Crown Prince Mohammed bin Salman in Washington Amid Strategic Deal Talks
Saudi Crown Prince to Press Trump for Direct U.S. Role in Ending Sudan War
Trump Hosts Saudi Crown Prince: Five Key Takeaways from the White House Meeting
Trump Firmly Defends Saudi Crown Prince Over Khashoggi Murder Amid Washington Visit
Trump Backs Saudi Crown Prince Over Khashoggi Killing Amid White House Visit
Trump Publicly Defends Saudi Crown Prince Over Khashoggi Killing During Washington Visit
President Donald Trump Hosts Saudi Crown Prince Mohammed bin Salman at White House to Seal Major Defence and Investment Deals
Saudi Arabia’s Solar Surge Signals Unlikely Shift in Global Oil Powerhouse
Saudi Crown Prince Receives Letter from Iranian President Ahead of U.S. Visit
Saudi Arabia’s Crown Prince Begins Washington Visit to Cement Long-Term U.S. Alliance
Saudi Crown Prince Meets Trump in Washington to Deepen Defence, AI and Nuclear Ties
Saudi Arabia Accelerates Global Mining Strategy to Build a New Economic Pillar
Crown Prince Mohammed bin Salman Arrives in Washington to Reset U.S.–Saudi Strategic Alliance
Saudi-Israeli Normalisation Deal Looms, But Riyadh Insists on Proceeding After Israeli Elections
Saudis Prioritise US Defence Pact and AI Deals, While Israel Normalisation Takes Back Seat
Saudi Crown Prince’s Washington Visit Aims to Advance Defence, AI and Nuclear Cooperation
Saudi Delegation Strengthens EU–MENA Security Cooperation in Lisbon
Saudi Arabia’s Fossil-Fuel Dominance Powers Global Climate Blockade
Trump Organization Engages Saudi Government-Owned Real-Estate Deal Amid White House Visit
Trump Organization Nears Billion-Dollar Saudi Real Estate Deal Amid White House Diplomacy
Israel Presses U.S. to Tie Saudi F-35 Sale to Formal Normalisation
What We Know Now: Donald Trump’s Financial Ties to Saudi Arabia
Saudi Arabia’s Ambitious Defence Wish List for Washington: From AI Drones to Nuclear Umbrella
Analysis Shows China, Saudi Arabia and UAE among Major Recipients of Climate Finance Loans
Why a Full Saudi–Israel Normalisation Deal Eludes Trump’s Reach
Trump Presses Saudi Arabia to Normalise Ties with Israel as MBS Prepares for White House Visit
US-Saudi Summit Set for November 18 Seeks Defence Pact and Israel Normalisation Momentum
Comcast CEO Brian Roberts Visits Saudi Arabia Amid Potential Bid for Warner Bros. Discovery
×