World Health Organization warns against using Remdesivir for COVID-19 treatment

Andrew Cummings
November 20, 2020

The World Health Organization has advised against the use of Gilead's remdesivir for patients hospitalised with Covid-19, saying there is a shortage of evidence that it improves the condition or reduces mortality. Additionally, the US FDA notably puts a massive trust in Remdesivir after granting a broad emergency authorization for its use.

"The fact that it was an antiviral that showed some benefit in certain trials - but not in all trials - was enough to push people to want to use it because we had no tools, but I do think it probably will be supplanted shortly", Adalja said, adding that the indication for drugs can change over time.

Remdesivir is now approved for use as a COVID-19 in over 50 countries and was one of the medications administered to US President Donald Trump when he was diagnosed in October.

"After thoroughly reviewing this evidence, the WHO GDG expert panel, which includes experts from around the world including four patients who have had covid-19, concluded that remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement", the group wrote in a press release. FDA typically convenes such a panel before deciding whether to approve a drug in situations where there are questions arising from clinical trial data.

The panel acknowledged that the certainty of the evidence is low, while also admitting the evidence did not prove that remdesivir has no benefit. They supported continued enrollment in trials evaluating remdesivir.

The health body analyzed results from clinical trials on patients hospitalized with the coronavirus around the world.

Gilead Sciences, the maker of remdesivir, which is sold under the name Veklury, said in a statement Thursday that the antiviral has been recommended by other organizations and countries based on "robust evidence from multiple randomized, controlled studies published in peer-reviewed journals". The EU, United States and several other countries rapidly granted temporary approval for the drug to be used on COVID-19 patients after it showed initial promise in shortening recovery time.

It noted, however, that given the remaining possibility of important harm, as well as the relatively high cost associated with remdesivir, which needs to be administered intravenously, the recommendation was "appropriate".

It was part of the treatment received by Donald Trump when he was hospitalised with COVID-19 symptoms, while in October the EU Commission struck a deal with Gilead to secure 500,000 doses.

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