Roche Submits Marketing Authorization Application for COVID-19 Treatment to EMA

According to an Oct. 11, 2021 press release, Roche has submitted a marketing authorization application for the monoclonal antibody combination therapy, Ronapreve (casirivimab/imdevimab), as a treatment for COVID-19 to the European Medicines Agency (EMA).

Ronapreve has been co-developed by Roche Registration and Regeneron Pharmaceuticals for the treatment of COVID-19 in adults and adolescents (12 years and older), who do not need supplemental oxygen therapy and who are at an increased risk of progressing to severe disease. Additionally, the combination monoclonal therapy has been developed for the prevention of COVID-19 in adults and adolescents aged 12 years and older.

Thanks to a rolling review of data that has been performed by EMA’s Committee for Medicinal Products for Human Use (CHMP), the agency is now able to assess the benefits-risk balance of Ronapreve in a shortened timeframe, with a potential opinion released in two months. The brevity of EMA’s assessment will be dependent upon the robustness of the data submitted and whether or not further information will be required.

Furthermore, the Pharmacovigilance Risk Assessment Committee of the EMA has already complete the preliminary assessment of the risk management plan and the agency’s Paediatric Committee has provided its opinion on the pediatric investigation plans for the combination drugs.

As soon as CHMP has provided its assessment on the benefit-risk balance of the therapy, EMA will provide further details. If the outcome from CHMP is positive, EMA will work closely with the European Commission to expedite the decision regarding marketing authorization for the product in the European Union.

Source: EMA