FDA authorizes remdesivir as outpatient therapy for covid-19 cases

Federal regulators Friday authorized the antiviral drug remdesivir for covid-19 outpatients at high risk of being hospitalized, providing a new treatment option for doctors struggling with shortages of effective drugs to counter the coronavirus.

The Food and Drug Administration said the intravenous treatment, which had been limited to patients in hospitals, could be administered to outpatients with mild-to-moderate illness.

Remdesivir, manufactured by Gilead Sciences, was among the first coronavirus treatments authorized in 2020. The drug received full agency approval later that year for people 12 and older. Treatment of younger children is permitted under an emergency use authorization, but Friday’s expansion to outpatients includes both age groups.

The FDA action was welcomed by physicians scrambling to keep covid patients out of the hospital as waves of infections crowd medical facilities. Among the hurdles for doctors: Two of the three authorized monoclonal antibody treatments are ineffective against omicron; there are shortages of the one antibody drug that still works; and demand for recently cleared antiviral pills sharply exceeds supply.

“The good news is it’s another tool in the treatment toolbox,” said Helen Boucher, an infectious-disease physician at Tufts Medical Center.

Because the medication had been approved for inpatient care, physicians are permitted to prescribe it “off-label” for patients not in the hospital. Boucher said she expects many more doctors and hospitals to begin treating outpatients with the medication now that the FDA has explicitly approved use for outpatients.

For the remdesivir treatment, patients must go to a clinic or hospital three days in a row, which may be difficult for some people. And the drug must be administered by skilled staff, which can present a logistical challenge as many hospitals are hobbled by personnel shortages.

The FDA said in a statement the treatment is not a substitute for vaccines, which remain the most potent protection against coronavirus.

But along with the two new anti-covid pills, the broader use of remdesivir will “bolster the arsenal of therapeutics to treat covid-19 and respond to the surge of the omicron variant,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said. She added that the drug can be administered at “skilled nursing facilities, home health-care settings and outpatient facilities such as infusion centers.”