The EU Strategy on COVID-19 Therapeutics delivered an announcement from the EU commission on the first portfolio of five therapeutics that could soon be available to treat patients across the EU.
Monoclonal antibodies
The four newly developed monoclonal antibodies under rolling review are:
- combination of bamlanivimab and etesevimab from Eli Lilly
- combination of casirivimab and imdevimab from Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd
- regdanivimab from Celltrion
- sotrovimab from GlaxoSmithKline and Vir Biotechnology, Inc.
A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency.
You can read more about the above and the regulatory status of other treatments and vaccines here.
Immunosuppressant
The immunosuppressant which has a marketing authorisation that could be extended to include the treatment of COVID-19 patients is baricitinib from Eli Lilly: an application for extension of marketing authorisation for COVID-19 indication is under assessment
About the portfolio of therapeutics
The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorisation by October 2021, the target set under the Strategy, provided the final data demonstrate their safety, quality and efficacy.
The Commission will draw up a portfolio of at least ten potential COVID-19 therapeutics by October, building on the work of the newly established expert group on COVID-19 variants.
The portfolio will contribute to the objective of having at least three new therapeutics authorised by October 2021 and possibly two more by the end of the year. The European Medicines Agency will start more rolling reviews of promising therapeutics by end 2021 subject to research and development outcomes.
Source: Europa website