FDA Says Remdesivir Can Now Be Used As Outpatient COVID Treatment

The US Food and Drug Administration (FDA) has announced an expansion in remdesivir treatment availability. With this change, certain individuals who have developed mild or moderate COVID-19 — but who haven't been hospitalized — can receive an infusion of the drug. The goal, the FDA says, is to prevent these individuals from ending up hospitalized.

Remdesivir, which is also called Veklury, has thus far been limited to COVID-19 patients hospitalized with the disease. The antiviral medication, which is given via an IV infusion, helps prevent COVID-19 from progressing to a severe state (via NIH). In light of the Omicron variant and record hospitalization numbers, the FDA has expanded the use of remdesivir to include some individuals who have contracted the disease, but who haven't been hospitalized.

In a statement about the agency's decision, FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni, MD, said, "On the heels of the FDA's recent authorization of two oral antiviral drugs, today's actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant."

Remdesivir treatment changes

Remdesivir has been approved for the treatment of COVID-19 patients; this expansion makes the treatment available to those who have tested positive for COVID-19, developed mild or moderate infections, but who haven't been hospitalized with the disease.

The expansion covers individuals ages 12 and older who weigh at least 88lbs, according to the agency, which notes that this change is intended for those who are at high risk of developing a severe infection. Beyond that, the EUA for using remdesivir as a COVID-19 treatment in kids under the age of 12 has also been expanded.

That EUA expansion covers high-risk patients who haven't been hospitalized, assuming they weigh between 7.7lbs and less than 88lbs. As well, the expansion allows for treating kids under the age of 12 as long as they weigh no less than 7.7lbs — again, if they are considered at high risk of hospitalization and death.

The agency notes that doses given to pediatric patients will be adjusted based on body weight. As well, the FDA warns remdesivir isn't a substitute for getting vaccinated — vaccines, including the booster shot, remain the best protection against COVID-19 infections.