Remdesivir: EU Commission Orders Much More From Gilead

ER Editor: You couldn’t make this up. So much has been said, observed and tragically experienced concerning Remdesivir’s capacity to cause kidney and liver damage.

Taxpayer money at work …


Remdesivir: new doses have been ordered by the European Commission from the Gilead laboratory


New order for the Remdesivir molecule from Gilead  AFP

On July 19, 2022, the Gilead laboratory signed a new joint supply agreement with the European Commission to deliver its antiviral molecule Veklury (Remdesivir) as part of severe treatment for Covid-19. Gilead will thus be able to continue to supply the member states of the European Union and the European Economic Area. The agreement secures purchases of the Veklury molecule over the next twelve months and can be extended for an additional six months.

Remdesivir from Gilead laboratories is an experimental treatment against Covid-19 which has not received any final authorization in Europe. Only a temporary cohort use authorization (ATUc) has been granted to it since July 15, 2020 by the National Medicines Safety Agency (ANSM).

Presented as a broad-spectrum antiviral, the molecule, limited to health establishments for patients on oxygen therapy and under renal and hepatic monitoring, cannot however be prescribed without first undergoing a collegial opinion. Administered intravenously, this drug is very complex to use because of the toxicity observed in both the kidneys and the liver.

On September 16, 2020, the Transparency Commission (CT) of the High Authority for Health (ER: a French institution, not European) published its opinion on the reimbursement of remdesivir in the indication of its conditional MA in the treatment of adults and adolescents affected by a severe form. of Covid-19.

Considering that the data available in this indication are preliminary with, in particular, uncertainties about the qualification of the therapeutic contribution of VEKLURY (remdesivir) compared to placebo, the Committee conditions the maintenance of its favorable opinion for reimbursement on the submission of data to D28 and in particular the mortality data from the American ACTT study with a submission expected as soon as they are available and at the latest in October 2020. On this occasion, the Committee will specify the clinical data to be collected in the context of real-life use of VEKLURY (remdesivir).

In addition, the Transparency Committee will reassess VEKLURY (remdesivir) in this indication when the consolidated results of the clinical studies are available (including the DisCoVeRy and SOLIDARITY trials) and when the national strategy for the management of COVID-19 evolves.’

The CT’s opinion was not the subject of a contradictory hearing with the Gilead laboratory, which decided to withdraw its request for access to reimbursement.

A few weeks later, on October 9, 2020, the publication of a very large study carried out in 405 hospitals, 30 different countries and 11,000 patients concluded that the hypothesis that remdesivir can prevent a substantial fraction of deaths is absolutely excluded“.

Following these results, on November 20, 2020, the World Health Organization (WHO) issued a press release in which it mentioned that ‘the antiviral drug remdesivir is not recommended for patients admitted to hospital with Covid-19, regardless of the severity of their illness. Because there is currently no evidence that it improves survival or that it avoids being placed on artificial ventilation.’

The poor results of this multicenter study – which are said to have been unknown at the time of the order signed on October 8, 2020 – had not prevented the European Commission from contracting with the pharmaceutical company for a purchase of 500,000 treatments intended to supply 36 countries. The price per vial was set at $390, for a total cost of $2,340 for a full five-day course with a 200mg loading dose on day one, followed by a 100mg dose on the next four days. .

Even today, when no study has come to provide proof of a significant benefit from treatment with remdesivir, it is surprising that the European Commission persists with this.




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