KUALA LUMPUR – The US Food and Drug Administration (FDA) has expanded the approval of the Covid-19 treatment remdesivir, or Veklury, to include patients aged 28 days and older.
The FDA said the patients must weigh at least 3kg and be either hospitalised for Covid-19, or have mild to moderate symptoms, with high risk for progressive severity.
This makes Veklury the first approved Covid-19 treatment for children less than 12 years of age. Earlier, Veklury was only approved by the FDA to treat certain adults and paediatric patients (12 years of age and older who weigh at least 40kg) who have Covid-19.
The regulatory body reminded that Veklury is not a substitute for vaccination in individuals for whom Covid-19 vaccination and booster doses are recommended.
It said that the approval of Veklury in certain paediatric patients is supported by efficacy results from phase three clinical trials in adults.
“This approval is also supported by a phase two/three, single-arm, open-label clinical study of 53 paediatric patients at least 28 days of age and weighing at least 3kg with confirmed SARS-CoV-2 infection and mild, moderate or severe Covid-19.
“Patients in this paediatric phase 2/3 trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the phase two/three study in paediatric subjects were similar to those in adults.”
The only approved dosage form is Veklury for injection.
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 (lips, around eyes, under the skin), rash, nausea, and sweating or shivering.
Veklury is developed by Gilead Sciences Inc. – The Vibes, April 26, 2022
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