top cx logo
cx logo
Explorearrow down
search icon
arrow down

European medicines regulator approves two new Covid treatments

Ronapreve and Regkirona are monoclonal antibody medicines that can be used to treat infected patients who do not yet require oxygen but who are at increased risk from the virus

Doctor holding vial of clear liquid

Ronapreve and Regkirona have been approved by the European Medicines Agency Pic: New Africa / Shutterstock

The European Medicines Agency (EMA) has recommended that marketing authorisation be given to two monoclonal antibody medicines used to treat Covid. 

Ronapreve, developed by Swiss pharmaceuticals company Roche, and Regkirona, created by South Korean laboratory Celltrion, are the first medicines of their type to be approved by the agency.

Ronapreve is recommended for use in adults and adolescents from 12 years of age who do not require supplemental oxygen but who are at increased risk from the virus.

Regkirona has also been approved for the same purpose, but only in adults. 

Both medicines were shown in trials to significantly reduce the chances of a vulnerable patient being hospitalised or dying from Covid.

Overall, 0.9% of patients treated with Ronapreve were hospitalised or died within 29 days of treatment, compared with 3.4% of patients on placebo. It also proved to be effective in stopping people from getting infected and developing symptoms after being exposed to the disease.

Regkirona trials showed that 3.1% of vulnerable patients given the drug were hospitalised, required oxygen or died within 28 days of treatment, compared to 11.1% in the placebo group.

Monoclonal antibodies are proteins that are created in a laboratory to bind to certain targets within the body, in this case the spike protein on the outer shell of SARS-CoV-2 (Covid), which the virus uses to penetrate human cells.

These antibodies – administered intravenously – are modelled on the antibodies humans produce naturally to tackle the disease. 

Stella Kyriakides, European Commissioner for Health and Food Safety, said that the approval of these medicines was an “important step” in the fight against Covid. 

“With the rise in Covid infections [that is currently occurring] in almost all member states, it is reassuring to see numerous promising treatments being developed,” she added.

The EMA will now send its recommendations to the European Commission for official approval.

Related stories 

New antiviral Covid pill to be reviewed by EU medicines agency
France will not rule on Covid vaccines for under-12s until early 2022
New American Covid pill not yet submitted for European approval

Resident or second-home owner in France?
Benefit from our daily digest of headlines and how-to's to help you make the most of life in France
By joining the newsletter, you agree to our Terms & Conditions and Privacy Policy
See more popular articles
The Connexion Help Guides
featured helpguide
Income Tax in France 2022 (for 2021 income)*
Featured Help Guide
- Primarily aimed at Britons, covers pensions, rent, ISAs, shares, savings and interest - Overview of online declarations + step-by-step guide to the French printed forms - Includes updates given automatically after this year's site opened
Get news, views and information from France
You have 2 free subscriber articles left
Subscribe now to read unlimited articles and exclusive content
Already a subscriber? Log in now