Gilead Covid-19 Drug Remdesivir Cleared by FDA

Gilead Sciences said the FDA cleared remdesivir to treat patients who have covid-19 and require hospitalization.
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Gilead Sciences  (GILD) - Get Report said Thursday that the U.S. Food and Drug Administration had cleared the drugmaker's antiviral remdesivir to treat coronavirus patients who require hospitalization.

Shares of the Foster City, Calif., company at last check were up 3.7% to $62.93.

The drug, which Gilead markets as Velkury, "is now the first and only approved covid-19 treatment in the U.S.," the company said. 

"The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply."

The FDA in May granted the drug emergency-use authorization, which allowed hospitals and doctors to use it for patients hospitalized with the disease.

The company said the drug should be administered only in a hospital, or in a health-care setting able to provide acute care comparable to in-patient hospital care.

Remdesivir earlier this month was reportedly in short supply following reports that President Donald Trump was using the drug as part of his medical regimen to combat his covid-19 diagnosis.

"Since the beginning of the covid-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Chief Executive Daniel O’Day said in a statement. 

“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as covid-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need."

Last week, Gilead shares had slipped after the World Health Organization said a study of remdesivir showed little impact on mortality rates or hospitalization times. 

The results contradict a study of remdesivir published in the New England Journal of Medicine, which detailed patient recoveries that were five days faster, as well as consistent and meaningful improvements in outcomes compared those given placebos in a double-blind Phase 3 study.