The U.S. Food and Drug Administration has granted a full final approval to Gilead Sciences Inc.’s remdesivir, making it the first Covid-19 treatment deemed safe and effective by the regulator, the company said Thursday.
Remdesivir has been widely used to treat hospitalized Covid-19 patients since May, when it received a provisional clearance from regulators known as an emergency-use authorization. Emergency authorizations are used to quickly get experimental drugs to patients without other treatment options in the event of biological and other threats.
Under the full-fledged approval, remdesivir is greenlighted to treat patients ages 12 years and older who require hospitalization for Covid-19. The FDA said remdesivir, which is sold under the brand-name Veklury, should be given via daily intravenous infusions for five days in most patients or 10 days among those on ventilators or life support.
It has shown modest effectiveness in clinical trials but has become the standard of care in hospitalized patients because of the dearth of other treatments.
Gilead had originally studied remdesivir as an Ebola treatment, but it proved less effective than other medicines treating that disease. When the new coronavirus was identified in January, the company was already working with academic researchers to study its potential in treating other coronaviruses, such as Middle East respiratory syndrome, or MERS. The company was soon helping supply clinical trials in China and eventually in the U.S.
“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,” Gilead Chief Executive Daniel O’Day said in a statement.
At the same time it issued a full approval, the FDA authorized remdesivir’s emergency use in patients younger than 12 years. Clinical trials testing the drug in those younger patients are ongoing.
The FDA approval is based primarily on a U.S. trial of 1,062 patients that found remdesivir sped up patients’ recovery time by five days compared with placebo. The study failed to show a statistically significant benefit in reducing deaths, however.
Analysts on average project global remdesivir sales of $2.3 billion in 2020 and $2.1 billion in 2021, according to FactSet.
“The formal FDA approval doesn’t change our estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval,” said Steven Seedhouse, a Raymond James analyst, in a note to clients.
Gilead shares rose 3.8% in after-hours trading following the approval.