BRIEF—EMA evaluating Ronapreve as COVID-19 therapy

The European Medicines Agency said today it has started evaluating an application for marketing authorization for the monoclonal antibody combination Ronapreve (casirivimab/imdevimab) submitted by Swiss pharma giant is Roche.

Ronapreve, co-developed by the USA’s Regeneron Pharmaceuticals and Roche, is intended for the treatment of COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID‑19, and for the prevention of COVID-19 in adults and adolescents aged 12 years and older.

The EMA will assess the benefits and risks of Ronapreve under a reduced timeline and could issue an opinion within two months, depending on the robustness of the data submitted and whether further information is required to support the evaluation.

Such a short timeframe is only possible because the EMA’s human medicines committee (CHMP) has already reviewed data on the medicine during a  rolling review.