FDA Approves First Drug to Treat COVID-19 Patients
By David Doolittle

NT_residencies

The Food and Drug Administration last week approved the first drug to treat COVID-19 patients – remdesivir, an antiviral drug that has shown to shorten hospital stays among patients.

In clinical tests, the drug, manufactured by Gilead Sciences under the name Veklury, shorted recovery times for hospitalized patients to 10 days, compared with 15 days for the placebo group, FDA said. In addition, patients who took the drug had greater odds of improved symptoms after 11 days than those who did not.

Veklury is approved for patients 12 years and older who require hospitalization for COVID-19, FDA said. The drug has been in use under an Emergency Use Authorization (EUA) since May and is the first COVID-19 treatment to receive full FDA approval.

Because the approval does not cover all pediatric patients, FDA also expanded the drug’s EUA for use in certain hospitalized patients younger than 12. Clinical trials on the drug’s effectiveness and safety for pediatric patients are ongoing, the agency said.

“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 risk,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

The drug, which stops replication of the coronavirus that causes COVID-19, is now widely available in hospitals across the country, Gilead Sciences said.

Texas hospitals had been receiving limited shipments of remdesivir through the federal government since May. Gilead took over nationwide distribution this month.

FDA published a frequently asked questions (FAQ) document that includes information on the drug, including side effects.

And check TMA’s COVID-19 Resource Center, for the latest news, resources, and tools on the pandemic.

Last Updated On

October 26, 2020

Related Content

Coronavirus

David Doolittle

Editor

(512) 370-1385

Dave Doolittle is editor of Texas Medicine and Texas Medicine Today. Dave grew up in Austin, where he attended culinary school as well as the University of Texas. He spent years covering Central Texas for the Austin American-Statesman newspaper. He is the father of two girls, a proud Longhorn, and an avid motorsports fan.

More stories by David Doolittle