Remdesivir gets FDA approval to treat Covid-19 patients - Trump
The Food and Drug Administration has granted emergency use authorisation for Gilead’s remdesivir drug to treat the coronavirus, the president said on Friday.
On Wednesday shares of Gilead Sciences Inc. GILD, -4.82% were up 6.8% in trading after it was rumoured that the Food and Drug Administration (FDA) was preparing to grant emergency use authorisation for remdesivir as a drug that could treat coronavirus.
Remdesivir given FDA approval
On Friday May 1 President Donald Trump announced that the FDA had green lighted Gilead to start experimental testing to fight Covid-19, “We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day told reporters. He added that the company is donating one million vials of remdesivir.
The regulatory action quickly follows positive trial results showing the drug helped coronavirus patients recover 31% faster than a group that received a placebo. Remdesivir has only been studied in hospitalised patients and is given as an IV infusion, so it's unlikely to become a broadly used treatment.
Emergency use authorisation
An emergency use authorisation is not the same as a typical approval. Emergency use is only allowed during public health emergencies, and treatments face a lower bar of evidence than used for FDA approval. There are no drugs that are specifically approved to treat Covid-19, the disease caused by the coronavirus.
"It is reasonable to believe that remdesivir may be effective in treating Covid-19," the FDA said in a letter authorising the drug's emergency use.
"When used under the conditions described in this authorisation, the known and potential benefits of remdesivir when used to treat Covid-19 outweigh the known and potential risks of such products."