(Reuters) -Europe’s drug regulator on Thursday recommended approving two COVID-19 therapies based on monoclonal antibodies, one developed by U.S. biotech firm Regeneron and Swiss giant Roche and another from South Korea’s Celltrion.
The approval was imminent amid a spike in coronavirus infections, Reuters had reported earlier this week, and marks the first approval for any COVID-19 treatment in the continent after Gilead’s remdesivir last year https://www.reuters.com/article/us-health-coronavirus-gilead-europe-idUSKBN23W1ZH.
Regeneron-Roche’s antibody cocktail, Ronapreve, has been backed https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines by the human medicines committee of the European Medicines Agency (EMA) for treating adults and adolescents who do not require oxygen support and are at high risk of severe disease.
Celltrion’s Regkirona, however, has been recommended only for adults with similar conditions.
While the evaluation of formal applications for authorising the medicines is under way, the two drugs are already available to some patients in the European Union as the EMA assisted member states on early use in some cases.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun Koyyur)
