The U.S. Food and Drug Administration on Thursday granted full approval to the antiviral drug remdesivir as a treatment for patients hospitalized with COVID-19, after conditional authorization was given in May.
Gilead said the drug, sold under the brand name Veklury, was the only specific treatment for COVID-19 approved so far under a more rigorous process.
However, other treatments have received authorization for emergency use, though that approval can be revoked once the public health emergency sparked by the coronavirus pandemic is over.
Other medications, like the steroid dexamethasone, are also being used in the fight against Covid-19.
Gilead’s shares on the New York Stock Exchange jumped four percent soon after the announcement.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen Hahn.
“Today’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.”
Europe and other countries such as Canada also have granted temporary approval for the use of remdesivir.
Remdesivir, which is administered by an injection, was one of the first drugs to show relative promise in shortening the time to recovery in some coronavirus patients.
But its efficacy in reducing the mortality rate is unproven.
It can be administered to adults and children over the age of 12 who weigh more than 40 kilos (88 pounds) who require hospitalization for the treatment of Covid-19, the illness caused by the novel coronavirus.
The drug can only be given to patients in a hospital or equivalent setting.
Emergency approval has been granted for its use on pediatric patients under the age of 12 weighing at least 3.5 kilos.
President Donald Trump, who tested positive for the coronavirus early in October, was treated with remdesivir at a military hospital outside Washington, among other drugs.❐
