FDA gives emergency authorisation to remdesivir

The US Food and Drug Administration has issued an emergency approval for Gilead Sciences’ potential coronavirus drug remdesivir, after positive results from a US-led trial were announced earlier this week. 

President Donald Trump said the regulator had issued an emergency use authorisation (EUA) for the antiviral, which the trial showed helped Covid-19 patients recover 31 per cent faster on average than without it.

Calling the drug “the hot thing”, he said it was an “important treatment for hospitalised coronavirus patients”.

Deborah Birx, a leading doctor on White House coronavirus task force said it illustrates what can happen in “such a short time”.

She said that from the first case being diagnosed in the US to the first step forward with a therapeutic was less than 90 days.

Shares in Gilead rose 0.5 per cent to $79.95 in after-hours trading in New York. The stock had closed down 4.8 per cent after analyst downgrades following an earnings call on Thursday that raised investor concerns that the company may not profit from the drug.

Daniel O’Day, Gilead chief executive, said the company was working to meet the needs of patients “with the greatest sense of urgency and responsibility”.

“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of Covid-19,” he said.

The FDA published guidance for patients taking remdesivir on its website, in which it said it had issued the EUA. 

“Remdesivir is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with Covid-19,” it said. “There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have Covid-19.”

The EUA follows another emergency approval the regulator issued for the antimalarial hydroxychloroquine.

Earlier this week, Mr Trump had said he wanted the drug to receive emergency approval as quickly as possible.

Anthony Fauci, the director of the National Institutes of Allergy and Infectious Diseases, which ran the trial, announced the results from the Oval Office on Wednesday. He said remdesivir had a “clear cut, significant effect”, and while it was not a “knockout”, could become the basis for other, better treatments for Covid-19.

The drug originally developed by the Californian biotech company for Ebola has not received full FDA approval — or approval from any other regulator in the world. On Thursday, Gilead said it would apply for full approval after obtaining the EUA. 

Remdesivir is given in an intravenous drip to patients in hospital. The FDA warned that possible side-effects include reactions to the infusion, such as low blood pressure and nausea, and potential liver problems.

The regulator warned that “not a lot of people have taken remdesivir”.

“Remdesivir is still being studied so it is possible that all of the risks are not known at this time,” it said.

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