European Commission Identifies 10 Most Promising Treatments for COVID-19

The European Commission (Brussels, Belgium) has established a portfolio of 10 potential COVID-19 therapeutics based on independent scientific advice that are likely to be authorized and therefore, available on the European market soon.

The establishment of the list delivers on a key action from the EU Strategy on COVID-19 Therapeutics which is an integral element of the work to build a strong European Health Union, and is modeled on the EU Vaccines Strategy which remains the EU's primary tool for ending the pandemic by preventing and reducing transmission of cases, as well as hospitalization rates and deaths caused by the disease. The Therapeutics Strategy aims to build a broad portfolio of COVID-19 therapeutics with the goal of having three to five new therapeutics available by the end of the year. It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use. The first list of five promising therapeutics was published in June 2021.

Now, a group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as the most promising for the EU portfolio of COVID-19 treatments, taking into account that different types of products are needed for different patient populations and at different stages and severity of the disease. The list of 10 candidates is divided in three categories of treatments and will continue to evolve as new scientific evidence emerges.

Within the category of antiviral monoclonal antibodies that are most efficacious in the earliest stages of infection, the Commission has identified Ronapreve, a combination of two monocolonal antibodies casirivimab and imdevimab from Regeneron Pharmaceuticals and Roche; Xevudy (sotrovimab) from Vir Biotechnology and GlaxoSmithKline; and Evusheld, a combination of two monoclonal antibodies tixagevimab and cilgavimab from AstraZeneca. Within the category of oral antivirals for use as quickly as possible after the infection, the Commission has identified Molnupiravir from Ridgeback Biotherapeutics and MSD; PF-07321332 from Pfizer; and AT-527 from Atea Pharmaceuticals and Roche. Among immunomodulators to treat hospitalized patients, the Commission has identified ctemra (tocilizumab) from Roche Holding; Kineret (anakinra) from Swedish Orphan Biovitrum; Olumiant (baricitinib) from Eli Lilly and Lenzilumab from Humanigen.

Six of the selected therapeutics are already under rolling review or have applied for marketing authorization to the European Medicines Agency. They could receive authorization soon, provided the final data demonstrate their quality, safety, and efficacy. The four other candidates on the list all received scientific advice from EMA, and once enough clinical data is collected, further rolling reviews can start.

“As we continue to face the challenge of COVID-19, it is important to shield ourselves in addition to vaccination. The establishment of 10 COVID-19 therapeutics will ensure that citizens receive the most promising treatments against the virus,” said Margaritis Schinas, Vice-President for Promoting our European Way of Life.

“Vaccination is the only tool to prevent COVID hospitalizations and deaths, and as such, it is the only way out of this pandemic,” added Stella Kyriakides, Commissioner for Health and Food Safety. “In the meantime however, COVID-19 patients do need safe and effective treatments to fight the infection, improve their prospect of a swift recovery, reduce hospitalizations and most importantly, to prevent loss of life. We have already signed four joint procurement contracts for different COVID-19 treatments and we stand ready to negotiate more. Our goal is to authorize at least three therapeutics in the coming weeks and possibly two more by the end of the year and help Member States gain access to them as soon as possible.”

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