The Food and Drug Administration approved the antiviral drug remdesivir for use in adult and pediatric patients who require hospitalization because of COVID-19.
The drug — which has a real name of Veklury — “should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care,” according to the FDA.
The drug has become the first treatment for COVID-19 to receive FDA approval.
FDA Commissioner Dr. Stephen M. Hahn explained the approval comes after multiple months of assessing data from the drug’s impact on people.
- “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” he said. “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. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
But this is a drug that has been in the news for the last few months as doctors and health experts have experimented with various treatments to keep people alive from the novel coronavirus.
What does remdesivir do? Does it work?
The Centers for Disease Control and Prevention called remdesivir an investigational intravenous drug that can have “broad” antiviral activity, as the Deseret News previously reported.
The drug is “is given through an IV and is designed to interfere with the virus’s ability to copy its genetic material,” according to the Associated Press.
And it has been used in the past to battle other coronavirus. The drug was made available early on in the fight against COVID-19 for “compassionate use” — like helping pregnant women and children who have COVID-19.
The timeline:
Remdesivir started making the news back in April when Gilead Sciences said the drug was effective against the novel coronavirus. The study tested the drug against usual care for hospitalized coronavirus patients. Specifically, the study said people recovered quicker after using the drug, according to The Associated Press.
Eight percent of those who took the drug died compared to 11% who died after taking a placebo, according to STAT News.
A study back in July tapped remdesivir as one of 21 different existing drugs that could stop the replication of the novel coronavirus, as I wrote about for Deseret News. The researchers said the drug might block the virus.
Sumit Chanda, Ph.D., professor at Sanford Burnham Prebys Medical Discovery Institute, specifically called out the impact of remdesivir as a successful treatment back in July.
- “Remdesivir has proven successful at shortening the recovery time for patients in the hospital, but the drug doesn’t work for everyone who receives it,” said Chanda. “That’s not good enough. As infection rates continue to rise in America and around the world, the urgency remains to find affordable, effective, and readily available drugs that can complement the use of remdesivir, as well as drugs that could be given prophylactically or at the first sign of infection on an outpatient basis.”
It wasn’t until May that the Food and Drug Administration gave emergency use authorization for some patients with COVID-19 to use remdesivir, as I wrote about for the Deseret News.
The approval came after Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, praised study findings about the drug.
- “The data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery.”