The U.S. Food and Drug Administration (FDA) has gone ahead with the approval of antiviral drug remdesivir as first treatment for COVID-19, notwithstanding last week's findings by the World Health Organization (WHO) that the drug is not effective for COVID-19 treatment.
Thursday, Gilead Sciences announced that the FDA approved remdesivir, sold under the brand name Veklury, for the treatment of patients with coronavirus (COVID-19) requiring hospitalization.
Last week, interim results from the Solidarity Therapeutics Trial, coordinated by the WHO, had revealed that Ebola drug remdesivir appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
The trial also evaluated malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir, with all three showing similar results as remdesivir.
The Solidarity Therapeutics Trial, which spanned more than 30 countries, was the world's largest randomized control trial on COVID-19 therapeutics which began six months ago. The study looked at the effects of these four treatments on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients.
However, Gilead immediately rejected the findings of the study, saying that they were inconsistent with "more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir)."
Gilead expressed concern saying, "the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion." The results of the trial are under review for publication in a medical journal and have been uploaded as preprint at medRxiv.
While approving the drug, the FDA said it is supported by data from multiple clinical trials that it has rigorously assessed. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19.
The FDA's approval of Veklury was based on data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
The U.S. and some other countries have been using remdesivir and hydroxychloroquine as a life-saving drugs against COVID-19, but there is no conclusive scientific evidence that these tablets can cure the infection from the novel pathogen.
On May 1, the FDA granted Veklury Emergency Use Authorization (EUA) to treat COVID-19. Gilead then submitted a New Drug Application (NDA) to the FDA for remdesivir on October 8.
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