Filenews 23 October 2021
The preparation of a portfolio of 10 possible pharmacotherapeutic agents against COVID-19 was prepared by the European Commission, according to a statement on Friday, basing its evaluation on independent scientific advice.
As noted, the candidate treatments against COVID-19 included in the portfolio are those that are likely to be approved and therefore soon made available on the European market, when they will be made available as treatments to patients across the EU, once their safety and efficacy are confirmed by the European Medicines Agency.
In a statement, Commissioner for Health and Food Safety, Stella Kyriakides, recalled that "vaccination is the only means to prevent hospitalizations and deaths due to COVID and is therefore the only way out of this pandemic".
But she added that in the meantime, however, COVID-19 patients need safe and effective treatments for rapid recovery, reduction of hospitalizations and, prevention of loss of life.
"We have already signed four joint procurement contracts for different treatments for COVID-19 and are ready to negotiate more. Our aim is to adopt at least three pharmacotherapeutics in the coming weeks and possibly two more by the end of the year and to help Member States access them as soon as possible," the Commissioner explained.
Commission Vice-President Margaritis Schinas said the challenge of COVID-19 continues to exist, it is important to have means of protection beyond vaccination.
"Our portfolio of 10 anti-COVID-19 pharmacotherapeutic tools will provide citizens with the most promising treatments against the virus," she stressed.
The selection was made by a team of independent scientific experts who examined 82 candidate pharmacotherapeutics within advanced stage of clinical development and singled out 10 candidates as the most promising for the COVID-19 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.
The list of ten candidates is divided into three categories of treatments and will continue to evolve as new scientific evidence emerges:
Antiviral monoclonal antibodies, which are the 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) by Vir Biotechnology and GlaxoSmithKline and
- 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 by Pfizer and
- AT-527 from Atea Pharmaceuticals and Roche.
Immunomodulators for the treatment of hospitalized patients:
- Actemra (tocilizumab) by Roche Holding,
- Kineret (anakinra) by Swedish Orphan Biovitrum,
- Olumiant (baricitinib) by Eli Lilly and
- Lenzimulab from Humaningen.
Six of the selected pharmacotherapeutic agents are already under rolling evaluation or an application has been submitted to the European Medicines Agency for marketing authorisation.
The communication notes that the selection of the 10 candidates is independent of the scientific evaluation by the European Medicines Agency or the approval of medicines by the European Commission, and does not replace them. A selected product may not be approved if the available scientific evidence does not meet the regulatory requirements as noted.
The other four candidates on the list received scientific advice from the EMA and, once sufficient clinical data have been gathered, further rolling evaluations can be launched.
As announced in the strategy on pharmacotherapeutic agents, a mechanism to promote innovation will support these therapeutic methods in the early stages of development.
The Health Emergency Preparedness and Response Authority (HERA) will create an interactive mapping platform for promising pharmacotherapeutic instruments. A call for tenders has been launched for the design of the platform.
An EU-wide matching event for the industrial production of pharmacotherapeutic agents will be organised in November to accelerate the development of new or retargeting drugs against COVID-19 and to mobilise the EU's pharmaceutical production capacity.
CNA
