Remdesivir now the first and only COVID-19 treatment approved for use in US, FDA says

Katie Camero
·2 min read

The U.S. Food and Drug Administration on Thursday approved the antiviral drug remdesivir for the treatment of hospitalized coronavirus patients in the U.S. — the first and only approved COVID-19 treatment as of yet.

The drug, named Veklury, was one of the three experimental treatments given to President Donald Trump while infected with SARS-CoV-2, the virus driving the pandemic.

The California-based biotechnology company that developed the drug, Gilead Sciences, said the antiviral is “widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply,” according to a news release.

“The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” Dr. Barry Zingman, professor of medicine at the Albert Einstein College of Medicine and Montefiore Medical Center in New York, said in the news release.

Zingman’s association or not with the clinical trials involving remdesivir is unknown.

“The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need,” he added.

The drug’s approval was based on the results of three randomized, double-blind controlled clinical trials that showed remdesivir “resulted in clinically meaningful improvements” in hospitalized coronavirus patients.

The company says the antiviral “significantly improved” coronavirus recovery time compared to placebo groups by five days, and by seven days in patients who needed oxygen support. Overall, the trials showed a trend of reduced mortality in patients receiving remdesivir by day 29 of treatment.

The drug is strictly for hospitalized adults and children 12 years of age and older. It should only be administered in a hospital or healthcare setting, the company said.