Remdesivir: EU authority recommends approval

Florian Tiefenböck studied human medicine at the LMU Munich. In March 2014, he joined as a student and has supported the editorial team with medical articles ever since. After receiving his medical license and practical work in internal medicine at the University Hospital Augsburg, he has been a permanent member of the team since December 2019 and, among other things, ensures the medical quality of the tools.

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The search for a suitable drug against the Sars-CoV-2 coronavirus continues. Now the European Medicines Agency (EMA) has for the first time recommended a drug for the treatment of Covid 19 patients for conditional approval: Remdesivir.

According to an official statement from the European Medicines Agency (EMA) on Thursday, the authority recommended restricted approval for the remdesivir (trade name Veklury). Accordingly, Remdesivir is to be approved for the Covid-19 treatment of adults and adolescents from 12 years of age. However, this only applies if the person affected has developed pneumonia from Sars-CoV-2 and needs additional oxygen.

The recommendation has to be approved by the EU Commission before the active ingredient can come onto the European market within the scope of this approval. According to the press release, the Commission will decide on this in the coming week.

Fast-track approval

The current recommendation is a so-called "conditional approval" of the active ingredient. It can be used when the need for treatment is particularly great, but the data on effectiveness and benefit are not yet available to the extent that is normally necessary.

Since April 30th, the Committee for Medicinal Products for Human Use has been gradually evaluating the data collected and in some cases provisional data from non-clinical tests, studies and compassionate use programs. They were submitted by the manufacturer of the now recommended drug, US biotech company Gilead Sciences. The manufacturer submitted the application for approval on June 5th.

After the now recommended approval, the EMA is demanding further data from the manufacturer on the benefits and safety of remdesivir by the end of the year. The company must submit proof of quality, but also data on the mortality rate, by the end of August.

Who should remdesivir help?

In its opinion, the agency relies primarily on the NIAID-ACTT-1 study, which was funded by the US Institute for Allergy and Infectious Diseases. The experts also used the data from other studies to provide support.

Ultimately, they came to the conclusion that the drug was more beneficial than harmful to patients who were seriously ill with Covid-19. They refer to people who have developed pneumonia and who need an additional supply of oxygen.

In the above study, a total of 1000 people were examined. The doctors treated the patients in one study group with remdesivir (10 days) and those in the other group with a placebo. It was found that the patients treated with the remdesivir had recovered about four days earlier than the participants in the placebo group.

However, the effect was only seen in seriously ill Covid 19 patients. The recovery time remained the same for patients with mild or moderate disease severity. Even in patients who are already ventilated and those whose blood has been enriched with oxygen via so-called extracorporeal oxygenation (ECMO), according to the data so far, there was no benefit from the remdesivir treatment.

Previous use

Remdesivir was originally developed to treat Ebola fever. As a Covid-19 drug, it has so far been used in the USA and Japan, among others. Japan had approved the manufacturer Gilead at the beginning of May. Remdesivir was also administered in Germany in accordance with an EMA recommendation: For the seriously ill as part of so-called compassionate use programs - if the person concerned no longer had any other treatment option.

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