Remdesivir Becomes First Coronavirus Treatment to Receive FDA Approval

By Dana Cruz First Posted: Oct 22, 2020 08:58 PM EDT

Maker Of Coronavirus Trial Drug Remdesivir, Gilead Sciences. Inc., Reports Positive Data Coming From Trials

(Photo : Justin Sullivan/Getty Images)
A sign is posted in front of the Gilead Sciences headquarters on April 29, 2020 in Foster City, California.

The U.S. Food and Drug Administration (FDA) approved remdesivir as a coronavirus treatment, Gilead Sciences said Thursday.

This move makes remdesivir as the first FDA-approved coronavirus treatment.

The FDA confirmed in a statement that remdesivir, which is sold under the brand name Veklury, was approved as a coronavirus treatment.

Gilead Sciences is the company that makes remdesivir.

Who Can Get Remdesivir Treatment?

Remdesivir can be given to adult and pediatric patients 12 years old or older. Patients receiving the antiviral drug have to weigh at least 40 kilograms or about 88 pounds for the treatment.

The drug should also be administered in a hospital or a "healthcare setting capable of providing acute care comparable to inpatient hospital care."

An emergency use approval (EUA) was given to the drug in May after the National Institutes of Health trial found how the drug had a modest effect on hospitalized patients' recovery time.

It is important to note that while it is an approved treatment, it does not prevent death from the virus, said New York Times.

In a statement, FDA Commissioner Stephen Hahn, M.D. said the agency is committed to a quick development of a coronavirus treatment.

"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," the statement read.

Remdesivir was one of the coronavirus treatments received by President Donald Trump after he showed symptoms earlier this month.

The World Health Organization sponsored a global study on the drug earlier this month. They found that remdesivir did not help in faster recovery or survival.

But a U.S. study found that it cuts recovery time for some patients by about a third, CNN reported.

What Does the FDA Approval Mean?

The formal approval from the FDA means the drug was cleared with more rigorous regulatory safeguards. It involved a more thorough review of the drug's clinical data and manufacturing quality since the EUA in May.

The FDA believes this approval represents "an important scientific milestone" amid the life-threatening pandemic.

Drugmakers submit data to the FDA if they are seeking approval. In seeking approval for remdesivir, Gilead Sciences submitted a study in the New England Journal of Medicine.

It showed the shorter course of illness that hospitalized patients experienced with the drug, from an average of 15 days to about 11 days.

There were also two other studies considered in approving the drug. One of those studies showed a slight benefit of the drug, while another said the drug did not make a difference.

The FDA also explained the process in its statement. They highlighted that the standards for the recent approval are different from the issuance of an EUA.

When the agency considers a drug for approval, they assess if the drug's benefits outweigh its risks.

Remdesivir was initially developed to be a treatment for Ebola and Hepatitis C. It interferes with the reproduction of viruses by jamming itself into new viral genes.

It did not go through an advisory committee, or an outside panel of experts, before receiving its FDA approval.