FDA Authorizes New Drug for Emergency Use on Hospitalized COVID-19 Patients

The Food and Drug Administration (FDA) on Thursday issued an emergency use authorization for an anti-inflammatory drug for hospitalized COVID-19 patients.

The drug, Actemra (tocilizumab), can be used for patients who are receiving steroids, supplemental oxygen, mechanical ventilation, or prolonged cardiac and respiratory support. In clinical trials, Actemra helped reduce mechanical ventilation and shorten hospitalization time. It lowered risks of death by about 5%. 

“This is a drug best utilized in patients who are severely ill,” Jason Gallagher, PharmD, a clinical pharmacy specialist in infectious diseases at Temple University Hospital, writes to Verywell. “It’s best utilized if patients are sick enough to require an ICU admission or who are close to one.”

Patients in the emergency or lower level of care are better suited for treatments like monoclonal antibodies if eligible, he adds.

“Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

As of June 25, 46% of the U.S. population is fully vaccinated against COVID-19 and 54% of the U.S. population has received at least one dose, according to the Centers for Disease and Prevention (CDC)’s COVID-19 data tracker.

COVID-19 cases among unvaccinated people in the U.S. are significantly higher—73%—than the standard national figures, according to The Washington Post. Hospitalization rates are likewise higher among unvaccinated individuals than those who have been vaccinated in several states, like Michigan, Pennsylvania, and Maryland.

“In America, we're seeing great responses to vaccination, but there are still pockets of the country where individuals have not been vaccinated,” Robert Quigley, MD, senior vice president and global medical director at International SOS, tells Verywell. “It's the unvaccinated people that I'm worried about the most, and they're the ones that are the most vulnerable.”

Actemra is an anti-inflammatory medication, not antiviral, meaning it doesn’t target SARS-COV-2 directly. Instead, it targets receptors inside a person’s white blood cells to fight off a hyperactive immune response. This is important in fighting off COVID-19, as the virus can cause a person’s immune system to be hyperactive and attack itself. While Actemra doesn't cure COVID-19 itself, it may be able to stop a potentially life-threatening side effect. 

But fighting off the virus takes more than providing individual cures, especially in the presence of hyper contagious variants, like the Delta variant, he adds. The virus can thrive and spread as long as it has a host—a person’s immune system—to hang onto.

“So long as the virus has a host in which it can function, we are never going to get ahead of this curve,” Quigley says. “Until that cycle is disrupted, we are always at risk of a mutation taking place that could be really, really deleterious to our entire community.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.