FDA approves sNDA for Veklury to treat pediatric patients who are older than 28 days and exposed to COVID 19.
Gilead Sciences, Inc. announced that the FDA has approved a supplemental new drug application (sNDA) for Veklury (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.
This approval follows the recent 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. 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. Veklury is contraindicated in patients who are allergic to Veklury or any of its components.
This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” said Amina Ahmed, MD, Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina in the United States. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
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