BioSpectrum Asia

USFDA approves first COVID-19 treatment for young children

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The US Food and Drug Administra­tion (FDA) has expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include paediatric patients 28 days of age and older weighing at least 3 kg (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are hospitalis­ed, or not hospitalis­ed and have mild-tomoderate COVID-19 and are at high risk for progressio­n to severe COVID-19, including hospitalis­ation or death. This action makes Veklury, by Gilead Sciences Inc., the first approved COVID-19 treatment for children less than 12 years of age. As a result of this, the agency also revoked the emergency use authorisat­ion for Veklury that previously covered the paediatric population. Before now, Veklury was only approved to treat certain adults and paediatric patients (12 years of age and older who weigh at least 40 kg, which is about 88 pounds) with COVID-19.

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