Following a positive recommendation from its medicines committee, the European Medicines Agency (EMA) has approved Regeneron’s antibody cocktail, Ronapreve (casirivimab/imdevimab).
The antibody therapy can be given to non-hospitalised patients (outpatients) aged 12 years or older who have confirmed COVID-19 and are at increased risk of progressing to severe COVID-19 but do not require oxygen supplementation.
The EMA also approved the therapy for the prevention of COVID-19.
“While the EU has one of the highest vaccination rates in the world, people will continue to fall ill and be in need of safe and effective treatments to fight infection and improve prospects not only of a faster recovery, but also of survival,” said Commissioner for Health and Food Safety, Stella Kyriakides. “The progression of the pandemic across the EU shows how fragile the situations still is and how important it is that COVID-19 patients have access to safe and effective treatments.”
She added that the EMA is also evaluating another six medicines that “could receive authorisation soon” if they can demonstrate their quality, safety and efficacy.
Dr George Yancopoulos, president and chief scientific officer at Regeneron said: “With today’s approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19. For non-hospitalised infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%, and in the prevention setting it reduced the risk of symptomatic infections by 82%.”
Yancopoulos also talked about “data not yet reviewed by the EMA” that suggests a single dose provides long-term protection against COVID-19 “beyond the currently authorised once-monthly dosing”.
Regeneron is working with Roche, the company that is primarily responsible for development and distribution of Ronapreve outside the United States. Regeneron and Roche had announced their intention to request an expansion of EMA approval to cover the treatment of patients who have been hospitalised due to COVID-19.
The antibody cocktail is already fully approved in Japan and conditionally approved in the United Kingdom and Australia, and has emergency or temporary pandemic use authorisations in 40+ countries including the US. The Food and Drug Administration accepted the treatment for priority review for non-hospitalised patients and prophylaxis in October.