Implementing a key action in the framework of the EU Therapeutic Strategy against COVID-19, the Commission is currently compiling a portfolio with 10 possible pharmacotherapeutic inside against coronavirus.
This list is based on independent scientific recommendations and focuses on the candidates treatments COVID-19 which are likely to be approved and therefore soon available on the European market.
These pharmacotherapeutic agents will provide immediate treatment to patients across the EU, provided that their safety and efficacy are confirmed by the European Agency Drugs (EMA), according to a relevant announcement.
THE vaccination against COVID-19 provides the best preventive protection against infections, serious illness, loss of life and the long-term consequences of the disease, the Commission adds. And although “vaccination is the best way to end the pandemic and return to normal life, we also ensure that COVID-19 therapies are available to treat those who are infected.”
THE Margaritis Schoinas, Vice-President of the Commission and Commissioner for the Promotion of the European Lifestyle, stated that “as long as we continue to face the challenge of COVID-19, it is important to have means of protection beyond vaccination. “The portfolio of 10 anti-COVID-19 pharmacotherapeutic agents that we are compiling will provide the citizens with the most promising anti-viral cures”.
The Commissioner for Health and Food Safety, Stella Kyriakidou, for her part, pointed out that “vaccination is the only means of preventing hospitalization and deaths due to COVID and, therefore, is the only way out of this pandemic. In the meantime, however, patients with COVID-19 need safe and effective treatments to fight the infection, improve their chances of a speedy recovery, reduce hospitalization and, most importantly, prevent loss of life.
We have already signed four joint procurement contracts for different COVID-19 treatments and are ready to negotiate more. Our goal is to approve at least three pharmacotherapies in the coming weeks and possibly two more by the end of the year and help the Member States to access them as soon as possible. “
According to the EIA, the EU strategy for pharmacotherapeutic agents against COVID-19 is an integral part of the work to build a strong European Health Union and builds on the EU’s successful vaccine strategy.
A team of independent scientific experts examined 82 candidate pharmacotherapists within an advanced stage of clinical development and singled out 10 candidates as the most promising for the COVID-19 disease treatment portfolio in the EU, taking into account that different types of products are required for different patient populations and at different stages and severity of the disease, according to the same report.
Three categories
The list of ten candidates is divided into three categories treatments and will continue to evolve as new scientific evidence emerges:
Antivirals monoclonal antibodies, which are most effective in the early stages of infection:
- Ronapreve, a combination of two monoclonal antibodies, casirivimab and imdevimab, from Regeneron pharmaceuticals and Roche.
- Xevudy (sotrovimab) from Vir Biotechnology and GlaxoSmithKline.
- Evusheld, a combination of two monoclonal antibodies, tixagevimab and cilgavimab, from AstraZeneca.
Oral antivirals to be used as soon as possible after infection:
- Molnupiravir, from Ridgeback Biotherapeutics and MSD.
- PF-07321332 from Pfizer.
- AT-527 from Atea Pharmaceuticals and Roche.
Immunoregulators for the treatment of hospitalized patients:
- Actemra (tocilizumab) from Roche Holding.
- Kineret (anakinra) by Swedish Orphan Biovitrum.
- Olumiant (baricitinib) by Eli Lilly.
- Lenzimulab from Humaningen.
Next steps
Six of the selected pharmacotherapeutic agents are already available under rolling evaluation the an application has been submitted to the EMA for their marketing authorization. They could get a marketing authorization soon, provided the final data proves their quality, safety and effectiveness.
The selection of the 10 candidates is independent of the scientific evaluation by the European Medicines Agency or the approval of the medicines by the European Commission, and does not replace them.
A selected product may not be approved, is clarified, if the available scientific data do not meet the regulatory requirements.
As announced, a mechanism to promote innovation will support these therapeutic methods in the early stages of development while the Emergency Health Preparedness and Response Authority (HERA) will create an interactive mapping platform for promising pharmacotherapeutic agents. In fact, a call for tenders for the design of the platform has already been announced.
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