Late to the party: Europe on the verge of approving Roche and Celltrion antibodies for COVID

neutralizing antibodies
The European Medicines Agency's committee's endorsement covers those who do not require supplemental oxygen and are at risk to progress to severe disease, while the Roche therapy was also recommended as a postexposure prophylaxis. (David Ho/Columbia University Irving Medical Center)

Nearly a full year after the U.S. gave Regeneron’s antibody cocktail for COVID-19 patients emergency authorization, Europe is on the verge of approving the monoclonal antibody duo. The European Medicines Agency's (EMA's) committee for human medicines also has recommended another antibody treatment for approval, Celltrion’s regdanvimab.

The EMA's Committee for Medicinal Products for Human Use has passed the recommendations to the European Commission for approval. The Regeneron cocktail of casirivimab and imdevimab, which is marketed outside of the U.S. by Roche and known commercially as Ronapreve, is recommended for COVID-19 patients who do not require supplemental oxygen and are at risk to progress to a severe form of the disease. It also is recommended for use as post-exposure prophylaxis. While the recommendations cover all adults, they also include adolescents 12 years or older weighing at least 40 kilograms, or roughly 88 pounds.

The recommendation for Celltrion’s regdanvimab, known commercially as Regkirona, covers the same subset of COVID-19 patients as Ronapreve's advice but only for adults and not in the preventive setting. Regkirona was approved for use in Celltrion’s home country, South Korea, in September.

The only other treatment approved for COVID-19 patients in Europe is Gilead’s Veklury, which is an antiviral treatment. It's Europe approval in June 2020 was for the same age groups but for a different population compared to Ronapreve and Regkirona—those already hospitalized with pneumonia and requiring supplemental oxygen. Veklury is also under review in Europe to extend its use to adults who do not require supplemental oxygen. 

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In June, the European Union acquired 55,000 courses of Ronapreve. Two months later, it received conditional marketing authorization in the U.K.

The EMA recommendation for Ronapreve was based on a study of 2,385 patients. It showed that 0.9% of those treated with Ronapreve were hospitalized or died within 29 days compared to 3.4% who were given a placebo.

Additionally, in a study of more than 200 people, of those treated with Ronapreve to prevent infection after a household member contracted the virus, 29% tested positive for COVID-19 as opposed to 42% of those received a placebo.

The recommendation for Regkirona was based on a study of 880 patients. While 3.1% of those treated with Regkirona were hospitalized, required oxygen or died, 11.1% provided placebo had those outcomes.

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The positive recommendations come more than four months after the European Union identified four monoclonal antibody treatments to prioritize for examination. One was GlaxoSmithKline and Vir Biotechnology’s sotrovimab, which was given emergency authorization in the U.S. in May of this year.

The other was Eli Lilly’s combination of bamlanivimab and etesevimab, which was initially given the go-ahead in the U.S. last year before losing its emergency authorization in June and then regaining it two months later. Last week, Lilly withdrew its application for approval of its antibodies in Europe because of a lack of demand.