EMA Approves Ronapreve and Regkirona for COVID-19 Treatment
Key Insights
The European Medicines Agency (EMA) has approved Ronapreve, developed by Roche and Regeneron, for treating COVID-19 (search) in patients over 12 who do not require oxygen and are at high risk of severe infection.
Regkirona, manufactured by Celltrion, has also been approved by the EMA for treating COVID-19 (search) in adults who do not require oxygen and are at high risk of severe infection.
Both antibody therapies have demonstrated favorable safety profiles, with the EMA noting only a small number of related reactions during clinical trials.
The European Medicines Agency (EMA) has granted approval to two antibody therapy drugs, Ronapreve and Regkirona, for the treatment of COVID-19 (search). This decision aims to provide additional therapeutic options as COVID-19 infections rise across member states.
Ronapreve, developed by Roche in collaboration with Regeneron Pharmaceuticals, consists of the active ingredients casirivimab and imdevimab. The EMA has approved Ronapreve for individuals aged 12 and older who do not require supplemental oxygen and are at high risk of progressing to severe COVID-19 (search).
Regkirona, developed by South Korean company Celltrion, contains the active ingredient regdanvimab. It has been approved for use in adults who meet similar criteria: those not requiring oxygen and at high risk of severe infection.
The EMA, based in Amsterdam, stated that the safety profiles of both drugs were favorable, with only a limited number of related adverse reactions reported during clinical trials. These approvals mark a significant step forward in expanding the arsenal of treatments available to combat COVID-19 (search) within the European Union. Prior to these approvals, remdesivir was the only drug approved by the agency for COVID-19 treatment.
Stella Kyriakides, the European Health Commissioner, welcomed the EMA's decision, stating, "With Covid-19 (search) infections increasing in almost all member states, it is reassuring to see many promising treatments in development... While the EU has one of the highest vaccination rates in the world, people will continue to get sick and need safe and effective treatments to fight infection and improve prospects not only for a faster recovery, but also for survival."
Before Ronapreve and Regkirona can be marketed within the EU, the European Commission must grant its final approval, a step considered a formality.