FDA approves emergency use of Gilead’s remdesivir for hospitalised COVID-19 patients

pharmafile | May 4, 2020 | News story | Sales and Marketing COVID-19, FDA, Gilead, coronavirus, remdesivir 

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.

The US regulator came to the ruling swiftly after the release of data from a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID) showed the drug met its primary endpoint in the treatment of hospitalised COVID-19 patients.

Findings emerging at the same time from Gilead’s own study comparing five-day and 10-day dosing regimens also factored into the ruling. With this emergency approval, the 10-day regimen is recommended for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), while the five-day regimen is suggested for patients without these requirements.

The FDA’s brief guidance indicated: “There is no US Food and Drug Administration (FDA) approved product available to treat COVID-19. Receiving remdesivir may benefit certain people in the hospital with COVID-19,” adding, “Remdesivir may help decrease the amount of the coronavirus in your body. This may help you to get better faster.”

The decision means that the drug will now be made available at a greater number of hospitals across the US; Gilead said that the currently limited supply of the therapy would be used in such a way that maximises access and availability for patients in urgent need of treatment, and this will coordinated by the US Government.

“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” remarked Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “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.”

With the approval, Gilead pointed out that it has already donated 140,000 courses of remdesivir, assuming all patients received a 10-day course, amounting to a total of over 1.5 million individual doses of the drug.

Matt Fellows

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