The European Commission picked four antibody treatments and a repurposed rheumatoid arthritis drug by Eli Lilly for an initial portfolio of preferred drugs to treat COVID-19.
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The EU Strategy on COVID-19 Therapeutics delivers its first outcome, with the announcement of the first portfolio of five therapeutics that could soon be available to treat patients across the EU.
Four of these therapeutics are monoclonal antibodies under rolling review by the European Medicines Agency. Another one is an immunosuppressant, which has a marketing authorisation that could be extended to include the treatment of COVID-19 patients.
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 products are:
A new COVID-19 indication for existing medicines:
• baricitinib immunosuppresant (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
Newly developed monoclonal antibodies under 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: under rolling review
• combination of casirivimab and imdevimab from Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd: under rolling review
• regdanivimab from Celltrion: under rolling review
• sotrovimab from GlaxoSmithKline and Vir Biotechnology, Inc.: under rolling review
The Commission will draw up a portfolio of at least 10 potential COVID-19 therapeutics by October, building on the work of the newly established expert group on COVID-19 variants.
The European Medicines Agency will start more rolling reviews of promising therapeutics by end-2021, subject to research and development outcomes.
The Commission recently concluded a joint procurement of monoclonal antibodies (casirivimab and imdevimab) and could launch more by the end of the year. ■