The US Food and Drug Administration (FDA) on Thursday approved Gilead Sciences, Inc.’s antiviral drug remdesivir for the treatment of patients admitted to Covid-19, making it the first and only drug approved for the disease in the United States.
Remdesivir, given intravenously, was one of the drugs used to treat US President Donald Trump during his fight with Covid-19.
The FDA’s formal approval came hours before the president’s final debate with Democratic rival Joe Biden ahead of the November 3 presidential election.
Remdesivir has been available under an FDA emergency approval (EUA) since May, after a study led by the National Institutes of Health showed that it reduced hospital stays by five days.
However, the World Health Organization (WHO) said last week that its global trial of Covid-19 therapies showed that remdesivir had no significant effect on patients’ hospital stays or chances of survival. The study has not been reviewed by external experts.
Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning patients and their physicians were aware of what treatments were being used.
Strap Div, which will be sold under the Veklury brand, costs $ 3,120 for a five-day treatment course or $ 2,340 for public purchasers such as the Department of Veterans Affairs. Gilead shares rose 4.3 percent after close to $ 63.30.
Positive result for Gilead
Remdesivir has become the standard of care for patients hospitalized with severe Covid-19, although it has not been shown to improve survival. The drug has also not been shown to significantly help moderately ill patients, and many doctors are still wary of using it for patients with less serious illness.
“Formal FDA approval does not change our (sales) estimates or prospects for belt deprivation, as it has already been labeled standard-of-care before formal approval,” Raymond James analyst Steven Seedhouse said in a research note, calling the prescribing guidelines. and approval “largely a best case for Gilead” given the WHO findings that question the benefits of belt drive.
Gilead said it is currently meeting demand for the drug in the United States and expects to meet global demand by the end of October.
The company said Veklury has regulatory approvals or temporary approvals in about 50 additional countries.
Also on Thursday, the FDA issued a new emergency use approval for remdesivir for the treatment of hospitalized pediatric patients under the age of 12 who weigh enough to receive an intravenous drug.
Gilead said it is still working to understand the full potential of belt devices in different environments and as part of combination therapy approaches. The company is also developing an inhaled version of the drug that can be used outside a hospital if approved.
( Jowharwith REUTERS)