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FDA Expands EUA Of Veklury For Non-hospitalized Adults, Pediatric Patients With COVID-19

gileadsciences oct23 24jan22 lt

The U.S. Food and Drug Administration (FDA) has granted approval and reissued the revised Emergency Use Authorization (EUA) to Gilead Sciences Inc. (GILD) for antiviral drug Veklury (remdesivir) to treat certain non-hospitalized adults and pediatric patients with mild-to-moderate COVID-19 disease.

The expanded use of Veklury now provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.

This expanded use will boosts the treatment options COVID-19, particularly to respond to the surge in infections of the omicron variant.

This will also allow patients who are at high risk of severe COVID-19 another treatment option that can be received outside of a traditional inpatient hospital setting. These include at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers.

The expanded use now includes pediatric patients weighing 3.5 kilograms to less than 40 kilograms or less than 12 years of age weighing at least 3.5 kilograms as well as adults of 12 years of age and older who weigh at least 40 kilograms.

This includes both adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization of death.

These high-risk non-hospitalized adults and pediatric patients may receive Veklury via intravenous infusion for a total of three days for the treatment of mild-to-moderate COVID-19 disease. They will receive doses adjusted for their body weight in order to achieve comparable exposures to adults and pediatric patients.

The approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 non-hospitalized patients. The Phase 3 trial data showed Veklury significantly reduced risk of hospitalization by 87% compared with placebo.

In the trial, 2 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.

This expanded approval by the FDA come amidst a surge in COVID-19 cases and the reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant.

On May 1, 2020, the FDA had issued a EUA for the emergency use of Veklury (remdesivir) for the treatment of hospitalized patients with severe 2019 coronavirus disease.

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.

Gilead will now work with distributors to make Veklury available in qualified outpatient facilities, including providing product information to non-hospital settings, to help meet the unprecedented demand for early treatment options brought on by the current COVID-19 surge.

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