Coronavirus cure? US govt approves remdesivir as official drug for Covid-19 treatment
London, May 2, 2020 (AltAfrica)-Gilead’s antiviral drug remdesivir has been authorised by US regulators for emergency use on coronavirus patients, President Donald Trump announced Friday.
US medical officials have announced evidence from a trial that remdesivir helped patients with serious cases of Covid-19 recover faster.
A statement from Gilead, the manufacturer of remdesivir says the optimal duration of treatment is still being studied in ongoing clinical trials.
“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. 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”
Gilead’s investigational antiviral for the treatment of COVID-19 receives @US_FDA Emergency Use Authorization. This more readily enables treatment of hospitalized patients with severe COVID-19 disease in the United States. Read more: https://t.co/p4LR0RM7sI. pic.twitter.com/4kg9oDQPRq— Gilead Sciences (@GileadSciences) May 1, 2020
During a meeting in the Oval Office with President Donald Trump, Gilead chief executive Daniel O’Day called the move an important first step and said the company was donating 1.5 million vials of the drug to help patients.
The FDA acted after preliminary results from a government-sponsored study showed that remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalised Covid-19 patients.
The study of 1,063 patients is the largest and most strict test of the drug and included a control group that received just usual care, so remdesivir’s effects could be rigorously evaluated.
Those given the drug were able to leave the hospital in 11 days on average, versus 15 days for the comparison group. The drug also might be reducing deaths, although that is not certain from the partial results revealed so far.
The National Institutes of Health’s Dr Anthony Fauci said the drug would become a new standard of care for severely ill Covid-19 patients like those in this study.
The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.
The FDA previously gave emergency use authorisation to a malaria drug, hydroxychloroquine, after President Donald Trump repeatedly promoted it as a possible treatment for Covid-19.
No large high-quality studies have shown the drug to work for that, however, and it has significant safety concerns.