FDA approves first COVID-19 treatment for young children

Yesterday, the US Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

This approval follows the recent supplemental new drug application (sNDA) approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, noted the drug’s developer, Gilead Sciences (Nasdaq: GILD), whose shares edged up 1.5% to $63.59 in after-hours trading.

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 five-day treatment course is recommended. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury. Gilead reported that Veklury fourth-quarter 2021 sales of the drug were $1.4 billion, down 30%, but still well ahead of analysts’ expectations of $864 million.  in the last three months of 2021, generating $1.4 billion,