Gilead’s Covid-19 treatment has been approved by the FDA

The Food and Drug Administration, or FDA on Thursday announced that it had approved Gilead Sciences’ remdesivir as a coronavirus treatment.

Following the announcement, shares of Gilead were up more than 5% after the closing bell.

The administration previously granted remdesivir an emergency authorization use for the treatment of Covid. The authorization allowed doctors to use the treatment on Covid-19 patients while the drug awaited formal approval by the FDA.

Remdesivir has proven effective to shorten the recovery time of hospitalized Covid-19 patients at the time. It was also the drug used to treat President Donald Trump after he tested positive for coronavirus earlier this month.

According to Gilead, the drug will be used on patients at least 12 years old, requiring hospitalization. The company emphasized that the drug should be administered in a hospital or health-care setting via an IV. The hospital or health-care center must be capable of providing acute care to patients.

Remdesivir is currently the only coronavirus drug that has been fully approved in the U.S. Data compiled by the John Hopkins University showed that more than 41.3 million people in the world have contracted the virus, and more than 1 million people worldwide have died from the virus. The drugmaker added that remdesivir is authorized for temporary use to treat coronavirus cases in about 50 countries worldwide.

“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” said Daniel O’Day, Gilead CEO, 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.”

According to a study by the World Health Organization earlier this month, it was stated that the remdesivir had “little or no effect” on death rates of hospitalized patients. However, the drug has shown some effectiveness in reducing recovery time for some hospitalized patients.

Some hospitalized patients who were treated with remdesivir received a five-day course with six vials of the drug. The company announced that it is also developing the inhaled version of the treatment, which will be administered through a nebulizer, a delivery device that turns liquid medicine into mist. It also said that the drug will not be administered in pill form because its chemical components could impact the liver.

Gilead said in August that it planned to produce more than 2 million treatment courses of the drug by December 31. It hopes to make “several million more” in 2021, with manufacturing networks across 40 companies in North America, Europe, and Asia. On Thursday, the company said it is currently meeting real-time demand for remdesivir in the U.S. and anticipates global demand before the month ends.

The remdesivir is now under the brand name, Veklury, and would cost $2,340 for a five-day treatment for patients under government health programs in the U.S, as well as in other countries. It would cost patients with private health coverage $3,120.