NEW YORK • The US Food and Drug Administration (FDA) has approved Gilead Sciences' antiviral drug remdesivir, making it the first drug to obtain formal clearance for treating the coronavirus.
Regulators had granted an emergency-use authorisation for remdesivir earlier this year, and since then, the drug has become a widely used therapy in hospitalised Covid-19 patients.
It was given to US President Donald Trump this month when he was diagnosed with the virus.
Thursday's approval for remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses and patients.
That could help solidify its position as a go-to medicine for Covid-19 patients even as other drugs for the disease begin to reach the market.
The nod for remdesivir came despite the World Health Organisation (WHO) last week saying that the drug did not have a substantial effect on patients' length of hospital stay or chances of survival in a global trial. That study has not been reviewed by outside experts.
Gilead has criticised the WHO study. In a letter posted on the company's website, chief medical officer Merdad Parsey said the findings do not negate other results.
Remdesivir has become the standard of care for patients hospitalised with severe Covid-19 even though it has not been shown to improve survival. The drug also has not been proven to significantly help moderately ill patients, and many doctors remain wary of using it in those with less severe illness.
FDA's approval is based on a US government-sponsored trial involving more than 1,000 hospitalised Covid-19 patients that found that those who received the drug recovered about five days faster than those who got a placebo.
The overall side effect rate was similar to the placebo in the study. The most common side effects are nausea and elevated liver enzymes, according to the product's label.
In the US on Thursday, several states, many of them in the Midwest, reported record single-day increases in coronavirus infections, further evidence that the pandemic is accelerating anew as cooler weather takes hold in many parts of the country.
Indiana, North Dakota, Illinois, Montana, Oklahoma, Utah and Ohio posted daily records, while Florida reported more than 5,500 new cases, its highest single-day increase since Aug 15.
Twenty-eight states have reported their daily record high of Covid-19 cases in this month alone.
On Wednesday, the number of coronavirus deaths reported across the country reached its highest in two months. Increases in deaths tend to trail spikes in new infections by several weeks.
Since the pandemic reached the US earlier this year, the nation has lost more than 222,000 lives, the world's highest total.
The autumn resurgence and dire predictions that the virus' spread would further accelerate in the cold winter months have once again cast a harsh spotlight on Mr Trump's handling of the pandemic.
With less than two weeks before the election, Mr Trump's seemingly dismissive approach to the virus has clouded his re-election prospects.
Along with spikes in cases and deaths, the number of Covid-19 patients in hospitals is also at a two-month high. There are more than 40,000 hospitalised patients now, up 33 per cent from Oct 1.
In Wisconsin, a Covid-19 hot spot and a pivotal battleground state that could help decide the presidential election, hospitals are feeling the strain from the surge in cases.
"We have a tremendous volume of patients in our hospitals right now," Dr Jeff Pothof, an emergency medicine physician at University of Wisconsin Health in Madison, said.
"I think a lot of the hospital systems in Wisconsin are feeling really stretched... It's that tightrope of meeting the need of Covid patients but not potentially harming patients who don't have Covid because we need to think about postponing their care."
The pandemic has also weighed on the finances of millions of Americans, who say they are barely getting by as Washington wrangles over another round of financial aid.
Chicago Mayor Lori Lightfoot on Thursday imposed a 10pm curfew for bars, restaurants and non-essential businesses in the city for at least the next two weeks, starting yesterday.
BLOOMBERG, REUTERS
