People suffering from COVID-19 should soon be able to receive better treatment in the EU.

UM – 10/2021

To date, Remdesevir has been the only specific medicine approved for the treatment of COVID-19 patients. Following the great success of the vaccination strategy, the European Commission also wants to see more action in the field of therapy. On 6 May, it had presented its Strategy for COVID-19 therapeutics in this regard (see also NEWS May 2021). The Commission has now published a list of the ten most promising therapeutics. They have been selected on the basis that they appear to be particularly suitable for individual patient groups at different stages of the disease.

A start has been made

The list builds on the release of five promising COVID-19 medicines from June of this year, but adopts only three products from those. It is to be updated regularly as the responsible expert group set up in July under the leadership of the Directorate-General SANTE - or more precisely HERA (European Health Emergency preparedness and Response Authority) - is pursuing a much broader spectrum of possible therapeutic options, which, however, still have to be conclusively proven in clinical trials. The purpose of the list is to provide guidance in order to effectively steer the assistance options provided by the European Union (EU). These include greater regulatory flexibility and scientific advice from the European Medicines Agency (EMA). 

Objective not quite reached

The self-set, ambitious strategic goal of having three new treatment alternatives available as early as October will apparently not be fully achieved. However, this should happen in the coming weeks. And two more therapeutics may be approved by the end of the year. Of the listed promising medicinal therapies, six are being reviewed by the European Medicines Agency (EMA).

Light at the end of the tunnel

An application for marketing authorisation of three medicines on the list has already been submitted. These are products that are already on the market for another indication. According to the European Commission in its press release of 25 October on the occasion of the publication of the list of medicines, a marketing authorisation could be granted by the end of the year in this case too, if the final test data proving the safety, quality and efficacy of the medicine is available in time.

In other words: the light at the end of the tunnel is clearly visible. As soon as the marketing authorisations are granted, the medicines can be jointly ordered. Four procurement contracts have already been concluded, although one relates to the already approved preparation Remdesevir.

Money should be used effectively

The Commission also indicates that it intends to actively support the most promising products and projects through a platform ("innovation engine"). Promising "candidates" for product development will be supported by opening up funding instruments such as Horizon Europe, InvestEU and EU4Health and by incentivising private investment.