EU strategy for COVID-19 therapeutics
Vaccination against COVID-19 offers the best preventive protection against infection, severe disease, loss of life, and long-term consequences of illness. While vaccination offers the best way to end the pandemic and get back to normal life, in parallel, we are ensuring that the COVID-19 therapeutics are available to treat those who are infected.
The European Commission’s strategy on COVID-19 therapeutics supports the development and availability of medicines, including for the treatment of ‘long COVID’, thus complementing the EU Vaccines Strategy, as part of the European Health Union.
See more: Covid 19 zdravljenje
Since the launch of the Strategy, several ‘rolling reviews’ by the European Medicines Agency (EMA) and joint procurement contracts for COVID-19 medicines have already been launched. The goal is to authorise at least three new therapeutics before the end of 2021. More than 75 COVID-19 treatments in development have already received scientific advice from the European Medicines Agency, including small molecules and monoclonal antibodies, antivirals, and immunomodulators. The European Medicines Agency is also evaluating several marketing authorisation applications for the treatment of COVID-19.
The Commission has established a portfolio of 10 potential COVID-19 therapeutics. The list 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 have been confirmed by the European Medicines Agency. These 10 therapeutics are:
- Antiviral monoclonal antibodies that are most efficacious in the earliest stages of infection:
- Ronapreve, a combination of two monoclonal antibodies casirivimab and imdevimab from Regeneron Pharmaceuticals and Roche.
- Xevudy (sotrovimab) from Vir Biotechnology and GlaxoSmithKline.
- Evusheld, a combination of two monoclonal antibodies tixagevimab and cilgavimab from AstraZeneca.
- Oral antivirals for use as quickly as possible after the infection:
- Molnupiravir from Ridgeback Biotherapeutics and MSD.
- PF-07321332 from Pfizer.
- AT-527 from Atea Pharmaceuticals and Roche.
- Immunomodulators to treat hospitalised patients:
- Actemra (tocilizumab) from Roche Holding.
- Kineret (anakinra) from Swedish Orphan Biovitrum.
- Olumiant (baricitinib) from Eli Lilly.
- Lenzilumab from Humanigen.
Questions and answers about the list of 10 candidate COVID-19 therapeutics
An initial list of 5 promising candidate COVID-19 therapeutics was already published on 29 June 2021. The five products below are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorisation soon provided that the final data demonstrate their safety, quality, and efficacy. The products are:
- baricitinib immunosuppressant (a medicine that reduces the activity of the immune system) from Eli Lilly: an application for extension of marketing authorisation for COVID-19 indication is under assessment by the European Medicines Agency.
Newly developed monoclonal antibodies under the European Medicines Agency’s rolling review – a regulatory tool to speed up the assessment of a promising medicine during a public health emergency:
- combination of bamlanivimab and etesevimab from Eli Lilly: 18 EU Member States have signed up to the joint procurement for the purchase of up to 220,000 treatments.
- combination of casirivimab and imdevimab from Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd: 22 EU Member States signed up to the joint procurement to buy 55,000 treatments.
- regdanvimab from Celltrion.
- sotrovimab from GlaxoSmithKline and Vir Biotechnology, Inc.: 16 EU Member States are participating in the procurement for the purchase of up to 220,000 treatments.
Questions and answers about the first 5 candidate COVID-19 therapeutics
The European Medicines Agency – COVID-19 treatments
The Commission also hosts pan-European matchmaking events to accelerate and scale up the development and production of therapeutics for COVID-19 in the EU. Following a first matchmaking event on COVID-19 medicines in July 2021, a second matchmaking event was held on 29-30 November 2021.
The Commission has signed a joint procurement framework contract with the pharmaceutical company Gilead for the supply of up to 500,000 treatment courses of Veklury, the brand name for Remdesivir. It is the only medicine with a conditional marketing authorisation in the EU for the treatment of COVID-19 patients who needing oxygen supply. All participating countries place their orders directly.
The Commission also purchased and distributed €70 million worth of doses of Remdesivir to Member States and the UK under the Emergency Support Instrument.
More information about new and ongoing projects