The U.S. Food and Drug Administration (F.D.A.) on Thursday approved Gilead Sciences's
"Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to his global health crisis," Gilead 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."
Remdesivir was first given an emergency use authorization (E.U.A.) by the F.D.A. back in May following a study led by the National Institutes of Health that demonstrated that the drug reduced COVID-related hospital stays by five days. According to the U.S. Centers for Disease Control and Prevention, the medium length of a hospital stay for coronavirus survivors is 10 to 13 days, so any drug that can reduce hospitalization is an asset with this type of disease.
Since its E.U.A., Remdesivir has become the standard of care for most hospitalized patients with severe COVID infection, with the drug notably being one of the treatments President Donald Trump received for his infection earlier this month.
However, the World Health Organization (W.H.O.) last week released the interim results from the agency's Solidarity Therapeutics Trial, with results indicating that remdesivir has "little or no effect" on death rates among hospitalized patients. The randomized study led by the global health agency included over 11,000 patients across 30 counties, with 2,750 given remdesivir as their primary treatment.
Gilead has since contested the results of the W.H.O.'s trial, stating that the agency's data is inconsistent with evidence from multiple randomized, controlled studies published in peer-reviewed journals. The W.H.O.'s study has not yet been peer reviewed.
Gilead had submitted the drug for approval in August, before the results of the Solidarity trial were published, meaning that the F.D.A. had approved of the drug with the W.H.O.'s data absent from their evaluation.
F.D.A. Commissioner Dr. Stephan Hahn stated that remdesivir's "approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic."
The F.D.A. has approved remdesivir, which will be sold under the brand name Veklury, for use in hospitalized coronavirus patients that are at least 12 years old. The drug is administered intravenously, with the majority of patients receiving a five-day course using six vials. Gilead is also developing an inhaled version of remdesivir that is intended to be used outside of a hospital setting.
Additionally on Thursday, the F.D.A. issued a new E.U.A. for remdesivir to treat hospitalized patients under the age of 12 as long as they meet a weight requirement.
Gilead stated that it is currently meeting demand for the drug within the United States and expects to meet global demand by the end of the month.
