EMA recommends approval of remdesivir for COVID-19 in the EU

26 June 2020

The European Medicines Agency has recommended granting a conditional marketing authorisation to Veklury, a remdesivir-containing product, for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This will make Veklury the first medicine for COVID-19 that is authorised in the EU.

Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. The assessment based on which the European Medicines Agency, EMA, has recommended remdesivir has been made within a very short timeframe through procedures applied in emergency situations.

The emergency procedure allows the EMA to recommend a medicine to be granted a marketing authorisation through a fast-track rolling review whereby the pharmaceutical companies submit their data for assessment by the EMA as they become available. This is different from the normal authorisation procedure according to which the companies submit all data at once after all tests have been completed.

Following a review of all the available data on remdesivir, the EMA has now assessed that the benefits of using remdesivir for the treatment of certain COVID-19 patients outweigh the risks. That is why the EMA now recommends the European Commission to grant a so-called conditional marketing authorisation for remdesivir.

A conditional marketing authorisation means that data are still being collected, that further studies are conducted and that a rigorous safety monitoring of possible adverse reactions is ensured after authorisation.

The European Commission aims to grant a decision on the conditional marketing authorisation for remdesivir as early as next week, in which case the medicine will be authorised for use against COVID-19 throughout the EU.

For patients with severe COVID-19

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.

In order to better document the efficacy and safety of remdesivir, the pharmaceutical company must provide further data on the medicine’s quality and on the efficacy in relation to mortality reduction by August 2020, and the final study data must be submitted by December 2020.

Read more about this here: First COVID-19 treatment recommended for EU authorisation.

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