Remdesivir EUA status : The US has officially pushed the use of remdesivir for treating the novel coronavirus with the Food and Drug Administration (FDA) granting emergency use authorization (EUA) to the investigational COVID-19 drug candidate being developed by Gilead Sciences.
The EUA lets the antiviral drug candidate to be used for the treatment of hospitalized COVID-19 patients.
According to the FDA, remdesivir is a direct-acting antiviral drug that blocks viral RNA synthesis. The investigational drug is not yet approved for any indication.
The FDA further said that the investigational COVID-19 drug has shown activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2.
The US drug regulator stated: “Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that remdesivir may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products.”
Besides, the FDA said that as of now there is no adequate, approved, and available alternative for COVID-19 treatment other than remdesivir.
Gilead Sciences said that the remdesivir EUA enables wider use of the antiviral drug candidate for treating patients hospitalized with severe coronavirus.
As of now, the optimal duration of treatment with the antiviral drug candidate has not been established and is being probed in ongoing clinical trials.
However, the FDA has suggested treatment with the investigational COVID-19 drug candidate for five or 10 days, based on the severity of the infection in patients.
Under the FDA’s EUA, five-day and also 10-day treatment durations have been suggested, which will be selected on the severity of the disease.
Remdesivir EUA status has been granted by the FDA based on the available findings from two COVID-19 clinical trials held across the world. One of them is a placebo-controlled phase 3 clinical trial by the National Institute for Allergy and Infectious Diseases in patients and the second one being Gilead Sciences’ own global phase 3 clinical study which is stuudying the five-day and 10-day dosing durations of the antiviral drug candidate.
Daniel O’Day – Gilead Sciences Chairman and CEO, commenting on the remdesivir EUA for COVID-19 treatment said: “This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19. We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile.
“We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.”