The US Food and Drug Administration (FDA) has granted authorisation to Gilead Sciences Inc. for emergency use of its experimental antiviral drug remdesivir to treat patients with Covid-19, President Donald Trump announced on Friday.
US medical officials have announced evidence from a trial that remdesivir helped patients with serious cases of Covid-19 recover faster.
Trump has been a vocal supporter of remdesivir as a possible way to bring the novel coronavirus pandemic under control. Nearly 65,000 Americans have died in the global crisis.
Initially developed by Gilead Sciences Inc. to combat Ebola, the treatment has proven to be effective against the various coronaviruses that have emerged since the early 2000s.
Gilead said on Wednesday the drug had helped improve outcomes for patients with Covid-19, the disease caused by the coronavirus, and provided data suggesting it worked better when given earlier in the course of infection.
The closely watched drug has moved financial markets in recent weeks, following the release of several studies that painted a mixed picture of its effectiveness.
Vice President Mike Pence said 1.5 million vials would start being distributed to hospitals on Monday.
Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases and a prominent member of the White House’s coronavirus task force, oversaw the US study on 1,063 patients in the US, Europe and Asia to test the effectiveness of the antiviral drug.
The data, Fauci told reporters earlier this week, “shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery” of Covid-19 patients. But a team of Chinese researchers published much less encouraging conclusions in the British medical journal The Lancet.
Their experiment, conducted on 237 severely ill patients in 10 hospitals in Hubei province (the region where the epidemic originated), appeared to indicate that remdesivir makes little difference. “Unfortunately, our study shows that this treatment does not provide any specific benefit compared to a placebo,” wrote Bin Cao, the main author of the article.