The Food and Drug Administration (FDA) took action Friday to expand the use of the antiviral remdesivir drug Veklury to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.
Previously, the use of the Gilead Sciences Inc. drug was limited to those requiring hospitalization.
"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," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release.
"Today’s actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers," she added.
The agency has expanded the approved indication for Veklury to include its use in adults and pediatric patients 12 years and older – and weighing at least 88 pounds – with positive results of direct SARS-CoV-2 viral testing and who are not hospitalized, have mild-to-moderate COVID-19 and are at high risk for progression to severe disease.
The FDA also revised Veklury's emergency use authorization (EUA) to also authorize the drug for treatment of pediatric patients less than 12 years of age, weighing at least 3.5 kilograms to less than 88 pounds, with the same conditions.
High-risk, non-hospitalized patients may receive Veklury via intravenous infusion for a period of three days.
The FDA said that the approval of Veklury for use in these patients is supported by a randomized, placebo-controlled clinical trial.
The trial included 562 hospitalized participants with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19.
"The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, two of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group," the FDA said.
It also noted that pediatric patients for whom the drug is authorized will receive doses adjusted to their body weight "In order to achieve comparable exposures to adults and pediatric patients receiving the approved dose."
In addition, FDA said that the authorization is based on extrapolation of efficacy from adequate and well-controlled studies in adults.
"Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease," Daniel O’Day, the CEO of Gilead Sciences, said in a separate statement. "While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a Phase 1 trial for our oral COVID-19 antiviral, GS-5245 is now underway."
Possible symptoms of Veklury include increased levels of liver enzymes, allergic reactions, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
Veklury is not a substitute for vaccination against COVID-19 in individuals for whom vaccination and boosters are recommended.
On Oct. 22, 2020 the FDA approved the drug application for Veklury for use in adults and pediatric patients ages 12 and older and weighing at least 88 pounds.
Notably, in December, Gilead Sciences announced that it was voluntarily recalling two lots of Veklury to the user level following a complaint of the presence of glass particulates.
In an FDA announcement, the company said then it had not received any reports of adverse events related to the recall.
Previous studies on remdesivir have shown conflicting results. In November 2020, the World Health Organization (WHO) recommended against the use of remdesivir in COVID-19 patients.