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
Ronapreve and Regkirona have been approved by the European Medicines Agency
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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.
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