Remdesivir for treatment of COVID-19 to continue in Denmark and Europe until further notice

Remdesivir for the treatment of hospitalised COVID-19 patients will continue in Denmark and the rest of Europe, awaiting the collection of further data that will provide conclusive evidence on the medicine’s efficacy and safety.

On Friday, the WHO issued a recommendation against the use of the antiviral agent remdesivir in COVID-19 patients after a WHO study showed that the medicine has no effect in the patients – including that the medicine does not reduce mortality. The European Medicines Agency (EMA) – in which Denmark is also represented – will include the WHO study in its overall review and assessment of remdesivir, which it has worked on since July when the European Commission issued a conditional marketing authorisation for remdesivir. Until the final assessment is available, Denmark and the other European countries will continue using remdesivir for the treatment of hospitalised COVID-19 patients.

The WHO study is an important element in the overall assessment of remdesivir

In early July this year, the pharmaceutical company having developed remdesivir was given a conditional authorisation – valid for one year – allowing them to market the product provided that they continuously collect further data on the medicine’s efficacy and safety.

After a year, the EMA will consider whether the authorisation granted needs to be adjusted. It will include the WHO study as well as data from other studies.

Data on which the conditional authorisation of remdesivir was given

Prior to issuing the conditional authorisation for remdesivir, the EMA reviewed all available data on remdesivir, concluding that the benefits of using remdesivir in COVID-19 patients outweigh the risks.

According to the EMA, the review of data showed overall that patients with severe COVID-19 who were treated with remdesivir recovered after 11 days, compared with 15 days for patients who did not receive remdesivir. This effect was not observed in patients with mild to moderate COVID-19 disease.

There was a positive benefit-risk balance in patients with pneumonia requiring supplemental oxygen, i.e. patients with severe COVID-19 disease.

Since then, a study in the New England Journal of Medicine also concluded that remdesivir had shortened the length of hospital stays in several corona patients.

New data constantly emerge, and these data are to be included in the overall assessment of the medicine.

Further reading: EMA recommends approval of remdesivir for COVID-19 in the EU. (in Danish only)

Danish Medicines Agency’s COVID-19 theme page: Vaccines and medicines against COVID-19.