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
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
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.