The EUA will enable wider use of remdesivir for treating hospitalised patients with severe Covid-19 disease, enabling access to the medication at more hospitals across the US, said the company.
According to Gilead Sciences, the optimal duration of treatment with the antiviral medication is currently being studied in ongoing clinical trials.
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.
Gilead Sciences revealed that the authorisation is temporary and will not replace the formal new drug application submission, review, and approval process.
The EUA permits for the distribution and emergency use of remdesivir only for the treatment of the novel coronavirus. The Gilead Sciences’ candidate will continue to be treated as an investigational drug as it has not been approved by FDA.
Gilead Sciences chairman and CEO Daniel O’Day 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.”
The FDA’s EUA has been granted based on available data from two clinical trials held globally, which include a placebo-controlled phase 3 study by the National Institute for Allergy and Infectious Diseases in patients with moderate to severe coronavirus symptoms. The other one is Gilead Sciences’ global phase 3 study which is assessing the five-day and 10-day dosing durations of the antiviral candidate in patients with severe disease.
Various other clinical trials are in progress to deliver more data on the safety and efficacy of remdesivir as a treatment for Covid-19, said Gilead Sciences.