US-based biopharmaceutical major Gilead Sciences said that the US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for investigational anti-viral remdesivir to treat COVID-19.
The EUA will facilitate broader use of remdesivir to treat hospitalised patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country.
"Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximise access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government," it said in a statement on Friday (local time).
Remdesivir is authorised for the treatment of hospitalised patients with severe COVID-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials.
Under the EUA, both five-day and ten-day treatment durations are suggested based on the severity of disease. The authorisation is temporary and does not take the place of the formal new drug application submission, review and approval process.
"The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19. Remdesivir remains an investigational drug and has not been approved by FDA," said Gilead.
"This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19," said Chairman and Chief Executive Officer Daniel O'Day.
"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 US government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19.
Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir.
Gilead said it is working with the US government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug under the EUA.