European Commission identifies 10 ‘promising’ COVID treatments

Regulatory NewsRegulatory News | 26 October 2021 |  By 

The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.
A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development. 
“In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: products preventing people who are exposed to the virus from becoming infected, reducing the need for hospitalisation, and preventing hospitalised patients from evolving to critical or dying,” the Commission said in a questions and answers document accompanying the announcement.
The announcement stems from the EU’s strategy on COVID-19 therapeutics, launched in May, to establish a portfolio of potential COVID-19 treatments and to bring up to 5 new COVID-19 therapeutics to market this year. (RELATED: EC strategy aims for 3-5 new COVID- therapeutics by year end, Regulatory Focus 6 May 2021)
The strategy also aims to set up an interactive mapping platform for promising therapeutics to analyze their development phases and production capacities by the second quarter of 2022. It includes more than €140 million in funding to streamline the development of promising new medicines.
The 10 candidates are divided into three categories of treatments: antiviral monoclonal antibodies, oral antivirals, and immunomodulators to treat hospitalized patients.
The antiviral monoclonal antibodies the Commission selected include Regeneron and Roche’s Ronapreve, a combination of casirivimab and imdevimab; Vir Biotechnology and GlaxoSmithKline’s Xevudy (sotrovimab); and AstraZeneca’s Evusheld, a combination of tixagevimab and cilgavimab.
The chosen antiviral candidates, which are to be used as quickly as possible after COVID-19 diagnosis, include Ridgeback Biotherapeutics and MSD’s molnupiravir; Pfizer’s PF-07321332; and Atea Pharmaceuticals and Roche’s AT-527.
The four immunomodulators to treat hospitalized patients are Roche’s RoActerma (tocilizumab), Swedish Orphan Biovitrum’s Kineret (anakinra), Eli Lilly’s Olumiant (baricitinib), and Humanigen’s lenzilumab.
Seven of these medicines are either under rolling review or have applied for a marketing authorization. Marketing authorization applications have been submitted for Ronapreve, Kineret, Olumiant and RoActerma. Xevudy, Evusheld and molnupiravir have been submitted for rolling review but have not yet been submitted for marketing authorization.
The selection criteria included the “soundness” of the scientific approach used in the medicine’s development; the progress in developing clinical outcomes from clinical trials; the absence of major safety issues; whether the treatment met an unmet clinical need; the suitability of the products for the particular healthcare setting; and the product’s likelihood of success.
According to the Q&A, “the expert group focused on the scientific/medical merits of the different therapeutics. Therefore manufacturing, production volumes, prices and access conditions have not been considered at this time.”
The COVID-19 therapeutics portfolio will be managed by the Health Emergency Preparedness and Response Authority (HERA), which is expected to be fully operational by early 2022.
In June, the EC released a portfolio of the initial five therapeutics being considered for authorization. The Q&A says that some of the five candidates identified on this earlier list did not make the cut. (RELATED: EC issues first COVID therapeutics portfolio, Regulatory Focus 29 June 2021).
The Commission’s decision to trim two of the therapeutics stems from “a more complex and multifactorial set of criteria” aimed at creating a more “balanced portfolio.” Three of the therapeutics from the original list, Ronapreve (casirivimab/imdevimab), Olumiant (baricitinib) and Xevudy (sotrovimab), made it to the list of ten. Celltrion’s regdanvimab and Eli Lilly’s monoclonal antibody combination of bamlanivimab and etesevimab did not make the cut.  
European Commission announcement
EC questions and answers document


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