DT News - India - US FDA grants Emergency Use Authorization (EUA) for the antiviral drug Remdesivir to treat COVID-19

Rajeev Chitguppi, Dental Tribune South Asia

Sat. 2 May 2020

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The US Food and Drug Administration has granted 'Emergency Use Authorization (EUA)' for Gilead Sciences’ antiviral drug remdesivir to treat COVID-19, the disease caused by the coronavirus. Remdesivir is now the first authorized therapy drug for COVID-19.

The experimental antiviral drug remdesivir has been approved by the US Food and Drug Administration to treat hospitalized patients with severe Covid-19.

The US FDA Commissioner Stephen Hahn said "This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with COVID-19 and is the first authorized therapy for COVID-19."

Remdesivir is a direct-acting antiviral drug that inhibits viral RNA synthesis. Remdesivir has activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2.

The US FDA has stated that "Based on a review of the topline data from the randomized, double-blinded, placebo-controlled trial conducted by NIAID (NCT04280705) and from the Gilead-sponsored open-label trial that evaluated different durations of remdesivir (NCT04292899), it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19."

Download the US FDA document by clicking here

The 'Emergency Use Authorization (EUA)' for remdesivir means that the drug remdesivir has not undergone the same level of review as an FDA-approved treatment.

The EUA letter says "Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19. Remdesivir is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19. Remdesivir was shown in a clinical trial to shorten the time to recovery in some people."

Download the EUA of remdesivir for the coronavirus disease (COVID- 19)

However, doctors will be allowed to use remdesivir on patients hospitalized with the disease, even though the drug has not been formally approved by the agency.

The company Gilead Sciences has also released the preliminary results from its own study, which shows improvement in at least 50% of the patients treated with a five-day course of remidesivir. The clinical trial was a single-arm study without a control (no -treatment) group. The trial had recruited 397 severe cases of COVID-19.

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