US President Donald Trump says emergency use of remdesivir has been approved by the Food and Drug Administration (FDA) for hospitalised patients who tested positive for coronavirus.
He made the announcement on Friday during a meeting with Daniel O’Day, chief executive officer of Gilead Sciences.
On Wednesday, Gilead Sciences, a biopharmaceutical company in the US, announced “positive data” in the clinical trial of remdesivir for the treatment of COVID-19.
In a statement issued on Friday, Gilead gave details of the emergency use authorisation (EUA) process for the drug.
Advertisement
“The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country,” it read.
“Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government.”
According to the statement, the use of the investigational antiviral remdesivir is authorised in patients with severe complications, while “the optimal duration of treatment is still being studied in ongoing clinical trials.”
Advertisement
“Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process,” it added.
“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.”
The statement also noted that the donation and distribution of remdesivir will be 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,” O’Day, said.
Advertisement
“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.”
Add a comment
