European Medicines Agency (EMA) has given a positive opinion on two COVID-19 treatments – Ronapreve and Regkirona – identified by the Commission as promising therapeutics under the EU Strategy on COVID-19 Therapeutics. Both are treatments for use during the early stages of infection based on antiviral monoclonal antibodies.
Welcoming this important progress under the Strategy, Commissioner for Health and Food Safety, Stella Kyriakides, made the following statement:
“With COVID-19 infections on the rise in almost all Member States, it is reassuring to see many promising treatments in development as part of our COVID-19 Therapeutics Strategy. Today we take an important step forward towards our goal of authorising up to five new treatments in the EU by the end of the year.
Vaccination remains the key tool to fight COVID-19, protect against infection, hospitalisation, loss of life and long-term consequences of illness. While the EU has one of the highest vaccination rates in the world, people will continue to fall sick 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.
Under our Therapeutics Strategy, we are also supporting Member States to have access to new medicines through our EU joint procurements. Two procurement agreements have already been concluded so far and negotiations are on-going for more COVID-19 therapeutics under assessment by EMA. Member States can already now call upon our contract for 55,000 treatments of Ronapreve. EMA is today evaluating another six medicines that could receive authorisation soon, provided the final data demonstrate their quality, safety, and efficacy. This swift progress under our ambitious Therapeutics Strategy shows what a strong European Health Union can deliver.
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. But what it shows even more, is that we must continue the vaccination drive, especially in those Member States with lower vaccination rates. Vaccination is the only preventive way out of the crisis.”
The EU Therapeutics Strategy aims to build a broad portfolio of COVID-19 therapeutics with the goal of having three to five new therapeutics available by the end of the year. It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use.
A first list of five promising therapeutics was published in June 2021. In October 2021 the Commission delivered on a key action by establishing a portfolio of 10 potential COVID-19 therapeutics. The list established is based on independent scientific advice, and focuses on COVID-19 treatment candidates that are likely to be authorised and therefore available on the European market soon. These therapeutics will bring treatment to patients across the EU as fast as possible provided that their safety and effectiveness has been confirmed by the European Medicines Agency. Both Ronapreve and Regkirona were included in the Commission’s list of five promising therapeutics in June 2021 and applied for marketing authorisation in October 2021.
The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve resilience of Europe’s health systems.