Among the five therapeutic candidates identified are Eli Lilly’s repurposed arthritis medicine Olumiant (baricitinib) and investigational antibody drugs for early-stage COVID-19.
This includes Lilly’s bamlanivimab and etesevimab combination, Roche and Regeneron’s REGEN-COV (casirivimab and imdevimab), Celltrion’s regdanivimab and GlaxoSmithKline/Vir Biotech’s sotrovimab.
The European Medicines Agency (EMA) is currently assessing an application for the extension of a marketing authorisation for Olumiant for COVID-19.
The four monoclonal antibodies selected for the EC’s COVID-19 Therapeutics Strategy are also currently being assessed under the EMA’s rolling review pathway.
“Today we are taking the first step towards a broad portfolio of therapeutics to treat COVID-19. While vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19,” said Stella Kyriakides, the EU Commissioner for Health and Food Safety.
“Our goal is clear, we aim to identify more front-runner candidates under development and authorise at least three new therapeutics by the end of the year. This is the European Health Union in action,” she added.
Now that it has identified the first five therapeutics as part of the strategy, the EC has committed to drawing up a portfolio of at least ten potential COVID-19 therapeutics by October 2021.
The expert group selecting the candidates is seeking to identify different types of products to span the different patient populations and stages and severity of COVID-19.
The overarching goal of the EU Strategy on COVID-19 Therapeutics is to build a comprehensive portfolio of medicines and aims to have three new therapeutics available by October 2021 and possibly two more by the end of 2021.
The therapeutics strategy works alongside the EU Vaccines Strategy, which is similarly aiming to authorise safe and effective vaccines for use against COVID-19.
Source PMLIvE
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