The Food and Drug Administration on Thursday approved remdesivir as a treatment for hospitalized coronavirus patients, Gilead Sciences said, making it the first FDA-approved drug for Covid-19.
KEY FACTS
The drug was previously granted an emergency use authorization in May, which allowed healthcare providers to administer the treatment even though it wasn’t formally approved by the FDA.
Remdesivir, which is sold under the brand name Veklury, “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” Gilead said.
The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.
Clinical trial data has been mixed: A randomized trial from the National Institute of Allergy and Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed, found last week the drug did not increase the chances of survival or result in faster recovery.
Gilead shares jumped 3.8% in after hours trading following the announcement.
CRUCIAL QUOTE
“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,” said Gilead CEO Daniel O’Day in a statement.
KEY BACKGROUND
President Donald Trump took remdesivir when being treated for the coronavirus earlier this month.
–By Rachel Sandler, Forbes Staff