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Covid-19: Remdesivir (updated on 31 May 2020)

Based on the new publications, the HCSP updates  guidelines published on May 15 on the criteria for distribution of remdesivir doses, as part of a joint approach with the Agence nationale de sécurité du médicament et des produits de santé (ANSM) (National Agency for the Safety of Medicines and Health Products).

The HCSP:

  • Confirms the difficulty in providing answers to the questions asked, due to the lack of consolidated data and therefore provides provisional recommendations.
  • Considers that the data available as of 31 May 2020 are insufficient to estimate the benefit/risk ratio of remdesivir based on the severity of the Covid-19 disease.
  • Stresses that the number of patients meeting the criteria of severe Covid-19 used in available studies and the European Medicines Agency (EMA) indications for a compassionate use of remdesivir is much higher than the number of doses proposed, making difficult any prioritization of patient groups for accessing remdesivir based on the potential benefit/risk ratio.
  • Stresses the mismatch between the number of patients hospitalized in intensive care units and the number of new cases hospitalized on 30 May 2020, the persistence of the virus circulation and the number of available treatments.
  • Is not able to propose an informed guideline on more precise prioritization criteria for the allocation of the number of treatments made available by the company or in the context of the expanded access to remdesivir compassionate use defined by the EMA.

 

* The confidential data communicated by the company to the Ministry of Health were blacked out in the published version of the guidelines.

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