Saudi Press

Saudi Arabia and the world
Monday, Jun 02, 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
Paris Saint-Germain's Greatest Triumph Is Football’s Lowest Point
OPEC+ Agrees to Increase Oil Output for Third Consecutive Month
Turkey Detains Istanbul Officials Amid Anti-Corruption Crackdown
Meta and Anduril Collaborate on AI-Driven Military Augmented Reality Systems
EU Central Bank Pushes to Replace US Dollar with Euro as World’s Main Currency
European and Arab Ministers Convene in Madrid to Address Gaza Conflict
U.S. Health Secretary Ends Select COVID-19 Vaccine Recommendations
Trump Warns Putin Is 'Playing with Fire' Amid Escalating Ukraine Conflict
India and Pakistan Engage Trump-Linked Lobbyists to Influence U.S. Policy
U.S. Halts New Student Visa Interviews Amid Enhanced Security Measures
Trump Administration Cancels $100 Million in Federal Contracts with Harvard
SpaceX Starship Test Flight Ends in Failure, Mars Mission Timeline Uncertain
King Charles Affirms Canadian Sovereignty Amid U.S. Statehood Pressure
Iranian Revolutionary Guard Founder Warns Against Trusting Regime in Nuclear Talks
UAE Offers Free ChatGPT Plus Subscriptions to Citizens
Lebanon Initiates Plan to Disarm Palestinian Factions
Iran and U.S. Make Limited Progress in Nuclear Talks
The Daily Debate: The Fall of the Dollar — Strategic Reset or Economic Self-Destruction?
Trump Administration's Tariff Policies and Dollar Strategy Spark Global Economic Debate
OpenAI Acquires Jony Ive’s Startup for $6.5 Billion to Build a Revolutionary “Third Core Device”
Turkey Weighs Citizens in Public as Erdoğan Launches National Slimming Campaign
Saudi-Spanish Business Forum Commences in Riyadh
Saudi Arabia and Spain Sign MoU to Boost SME Sectors
UK Suspends Trade Talks with Israel Amid Gaza Offensive
Iran and U.S. Set for Fifth Round of Nuclear Talks Amid Rising Tensions
Russia Expands Military Presence Near Finland Amid Rising Tensions
Indian Scholar Arrested in Crackdown Over Pakistan Conflict Commentary
Israel Eases Gaza Blockade Amid Internal Dispute Over Military Strategy
President Biden’s announcement of advanced prostate cancer sparked public sympathy—but behind closed doors, Democrats are in panic
A Chinese company made solar tiles that look way nicer than regular panels!
Indian jet shootdown: the all-robot legion behind China’s PL-15E missiles
The Chinese Dragon: The True Winner in the India-Pakistan Clash
Australia's Venomous Creatures Contribute to Life-Saving Antivenom Programme
The Spanish Were Right: Long Working Hours Harm Brain Function
Did Former FBI Director Call for Violence Against Trump? Instagram Post Sparks Uproar
US and UAE Partner to Develop Massive AI Data Center Complex
Apple's $95 Million Siri Settlement: Eligible Users Have Until July 2 to File Claims
US and UAE Reach Preliminary Agreement on Nvidia AI Chip Imports
President Trump and Elon Musk Welcomed by Emir of Qatar Sheikh Tamim with Cybertruck Convoy
Strong Warning Issued: Do Not Use General Chatbots for Medical, Legal, or Educational Guidance
Saudi Arabia Emerges as Global Tech Magnet with U.S. Backing and Trump’s Visit
This was President's departure from Saudi Arabia. The Crown Prince personally escorted him back to the airport.
NVIDIA and Saudi Arabia Launch Strategic Partnership to Establish AI Centers
Trump Meets Syrian President Ahmad al-Shara in Historic Encounter
Trump takes a blow torch to the neocons and interventionists while speaking to the Saudis
US and Saudi Arabia Sign Landmark Agreements Across Multiple Sectors
Why Saudi Arabia Rolled Out a Purple Carpet for Donald Trump Instead of Red
Elon Musk Joins Trump Meeting in Saudi Arabia
Trump says it would be 'stupid' not to accept gift of Qatari plane
Quantum Computing Threatens Bitcoin Security
×