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EMA provides the recommendations for the use of remdesivir in patients
with COVID-19 who are not eligible for clinical studies and are at high risk.
Issued in the press release on 3rd April 2020
by the European Medical Agency's (EMA); the Committee for Medicinal Products
for Human Use (CHMP) presented the recommendations on the use of remdesivir for
COVID-19 treatment in compassionate use programmes. These recommendations were
provided in an extraordinary virtual meeting held on 2 April 2020.
The compassionate use programmes are set in
the European Union (EU) at individual EU Member States level in which the
treatment options for life-threatening conditions with no marketed drugs
available are provided, these drugs could be in clinical trials and are used
under strictly controlled conditions.
The Estonia, Greece, the Netherlands and
Romania had requested the opinion of CHMP for the use of remdesivir in COVID-19
patients. If severe, COVID-19 causes severe acute respiratory syndrome,
pneumonia, multi-organ failure and death.
Dr Harald Enzmann, the chair of the CHMP said
that, though the data from clinical trials about the efficacy and safety of
investigational medicinal products remains the gold standard, the compassionate
use programmes are needed for remdesivir in COVID-19 patients who are not
eligible for clinical trials.
The investigational drug remdesivir has found
to be active against coronaviruses (SARS-CoV-2, SARS-CoV and MERS-CoV) in
studies but with a limited data of its efficacy and safety in COVID-19.
The CHMP wants to ensure the use of common approach criteria to be followed prior to the compassionate use programmes by the Member States. The CHMP describes the recommendations for the use of remdesivir and for the patients it is intended to be used during the compassionate use programmes.
European Medical Agency (Press release 03.04.2020)
https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19
EMA provides recommendations on compassionate use of remdesivir for COVID-19.
Dr Janet König. (Rapporteur)
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