The EU’s COVID-19 treatment strategy is yielding a first result today, with the announcement of the first portfolio of five treatments that may soon be available to treat patients across the EU. Four of these treatments are monoclonal antibodies that are subject to continuous evaluation by the European Medicines Agency. The fifth is an immunosuppressant with a marketing authorization that could be extended to the treatment of covid-19 patients.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “Today we are taking the first step towards establishing a broad portfolio of COVID-19 treatments. Although vaccination is progressing at an increasing rate, the virus is not going away and patients will need safe and effective treatments to reduce the pressure of COVID-19. Our goal is clear: to identify other pioneering candidates under development and to authorize at least three new treatments by the end of the year. This is the European Health Union.”
The five products are at an advanced stage of development and have a high chance of being among the three new treatments for COVID-19 that will be cleared by October 2021 — the goal set under the strategy — provided that the final data demonstrate their safety, quality and efficacy. These are the following products:
a new COVID-19 indication for existing medicines:
- Eli Lilly’s immunosuppressant baricitinib (a medicine that reduces the activity of the immune system): an application to extend the marketing authorization to include the indication for COVID-19 is under consideration;
newly developed monoclonal antibodies subject to continuous evaluation — a regulatory tool to accelerate the evaluation of a promising medicinal product in the event of a public health emergency:
- Eli Lilly’s combination of bamlanivimab and etesevimab: continuous evaluation;
- the combination of casirivimab and imdevimab from Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd: ongoing evaluation;
- Celltrion regdanvimab: continuous evaluation;
- GlaxoSmithKline’s sotrovimab and Vir Biotechnology, Inc.: ongoing evaluation.
Timeline
The Commission will develop by October a portfolio of at least 10 potential treatments for COVID-19, building on the work of the recently established Expert Group on COVID-19 Variants. The selection process will be objective and based on scientific data, with the selection criteria agreed with the Member States. Since different types of products are needed for different patient populations and different stages and degrees of disease severity, the expert group will establish product categories and select the most promising treatment candidates for each category, based on scientific criteria.
The portfolio will contribute to the goal of having at least three new treatments authorized by October and possibly two more by the end of the year. The European Medicines Agency will launch further ongoing evaluations of promising treatments by the end of 2021, based on research and development results.
The Commission has recently concluded a joint procurement agreement for the acquisition of monoclonal antibodies (casirivimab and imdevimab) and may launch further procedures by the end of the year.
The first industry linking event regarding treatments will be held on July 12 and 13 to ensure that once authorized, treatments are produced in sufficient quantities, as quickly as possible.
Context
The EU’s COVID-19 Treatment Strategy aims to build a broad portfolio of COVID-19 treatments with the aim of having three new treatments available by October 2021 and possibly two more by the end of the year. It encompasses the entire life cycle of medicines, from research, development, selection of promising candidates, rapid regulatory approval, manufacture and deployment to their end use.
The strategy is part of the strengthening of a European Health Union, which is based on a coordinated EU approach to better protect the health of our citizens, with the aim of empowering the EU and its Member States to better prevent and respond to future pandemics and improve the resilience of European health systems.
This strategy, which focuses on the treatment of COVID-19 patients, is a continuation of the EU’s proven Vaccine Strategy, in which the use of safe and effective COVID-19 vaccines has been authorized in the EU to prevent and reduce the transmission of cases, and rates of hospitalization and death caused by the disease.
Learn more
Q&A: COVID-19 treatment strategy — list of 5 treatment candidates
European Commission response to coronavirus: treatments
European Medicines Agency — treatments for COVID-19
Source:
La Commission recense cinq candidats traitements prometteurs (europa.eu)
