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FDA Approves Gilead's Remdesivir To Treat Young Children With COVID-19

The U.S. Food and Drug Administration has approved Gilead Sciences Inc.'s (GILD) Veklury or remdesivir for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death, the company said in a statement on Monday.

The approval makes Veklury the first approved COVID-19 treatment for children less than 12 years of age.

Previously, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms) with COVID-19.

Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended.

Possible side effects of using Veklury include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.

Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program.

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