European Commission Starts Implementing EU Strategy for Covid-19 Therapeutics
- 30/06/2021
- Articles
On 29 June 2021 the European Commission (the Commission) unveiled a portfolio of five candidate therapeutics for the treatment of COVID-19 patients (see, attached Commission press releases). The announcement forms a first step in the roll-out of the Commission’s EU strategy for Covid-19 therapeutics (the Strategy) (see, Van Bael & Bellis Life Sciences News and Insights of 7 May 2021).
Four of these therapeutics are antiviral monoclonal antibodies which are all under rolling review by the European Medicines Agency (EMA):
- a combination of bamlanivimab and etesevimab (Eli Lilly);
- a combination of casirivimab and imdevimab (Regeneron Pharmaceuticals, Inc. and F. Hoffmann-La Roche, Ltd);
- regdanivimab (Celltrion); and
- sotrovimab (GlaxoSmithKline and Vir Biotechnology, Inc.).
The fifth medicine under review is the immunosuppressant baricitinib (Eli Lilly) which reduces the activity of the immune system and for which a new indication directed at the treatment of COVID-19 patients is under consideration.
The Commission plans to draw up a wider portfolio of potential COVID-19 therapeutics by October 2021, building on the work of the newly established expert group on COVID-19 variants which works under the aegis of the Health Emergency Preparedness and Response Authority (HERA). As indicated in the Strategy, the Commission hopes to have at least three new therapeutics authorised by October 2021 and possibly two more by the end of 2021. For its part, EMA will start additional rolling reviews of promising therapeutics by the end of 2021. The new portfolio of products may benefit from regulatory flexibility which involves, in addition to rolling reviews, conditional marketing authorisations and flexible labelling and packaging requirements.
Other aspects of the Strategy which the Commission has already implemented include a joint procurement procedure for casirivimab and imdevimab; and an industry matchmaking event that will take place on 12 and 13 July 2021 to create production capacity for authorised therapeutics.
