Antiviral Approved for Treating Non-Hospitalized Adults and Children at High Risk for COVID-19 Disease Progression

The U.S. Food and Drug Administration (FDA) recently granted expedited approval of an innovative antiviral for treating non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19.

On January 21, 2022, the FDA issued a supplemental new drug application (sNDA) for Veklury® (remdesivir). This nucleotide analog has been the antiviral standard of care for treating patients hospitalized with COVID-19.

In the United States, Veklury is now indicated for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) who are either hospitalized or not hospitalized but are at high risk for progression to severe COVID-19, including hospitalization or death.

Veklury is additionally authorized for these uses under the Emergency Use Authorization (EUA) for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg. 

Under the expanded indication for Veklury, non-hospitalized adult and pediatric patients (12 years of age and older and weighing at least 40 kg) with confirmed SARS-CoV-2 infection who are at high risk for COVID-19 disease progression can be treated with a recommended treatment duration of three days to help prevent hospitalization. 

The only authorized dosage form of Veklury for use in pediatric patients under the EUA is 100 mg for injection, supplied as a lyophilized powder. 

For hospitalized patients not on mechanical ventilation and/or ECMO, a 5-day course of treatment is recommended, with the option to extend to a total of 10-days as needed. 

Critically ill patients who require mechanical ventilation and/or ECMO should receive a 10-day course of treatment.

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, commented in a press release issued on January 21, 2022, “Today’s actions provide (certain) adults and pediatric patients, with mild-to-moderate 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.” 

The FDA sNDA approval, pediatric EUA expansion, and the updated National Institutes of Health Treatment Guidelines for COVID-19 published on January 19, 2022, are based on results from the PINETREE Phase 3 randomized, double-blind, placebo-controlled trial. 

An analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo demonstrated that treatment with Veklury resulted in a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. 

And the safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment-emergent adverse events (≥5%) in patients taking Veklury being nausea and headache.

“Remdesivir (Veklury) 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,” stated Daniel O’Day, Chairman, and CEO, Gilead Sciences, in a related media statement. 

“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.”

To meet the expanding demand in the U.S., Gilead is collaborating with distributors to make Veklury available in qualified outpatient facilities. In addition, Gilead intends to enable outpatient ordering in a tiered approach that will start with hospital outpatient departments due to their experience and familiarity with the administration of Veklury. Then outpatient ordering will become available to other qualified outpatient facilities.

Veklury is contraindicated in patients who are allergic to Veklury or any of its components; drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Furthermore, there are insufficient human data on the use of Veklury during pregnancy. 

Please review the additional Important Safety Information for Veklury.  

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