CHMP recommends expanded approval for Veklury to treat pediatric patients with COVID 19
CHMP a committee of the European Medicines Agency (EMA) recommended the approval of expanded use of Gilead Sciences' Veklury (remdesivir) to treat pediatric patients who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19
The EMA's Committee for Medicinal Products for Human Use (CHMP) also issued positive opinion for approval of Veklury's use in children 4 weeks of age and older with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The CHMP's decision was backed by data from an ongoing phase II/III trial called CARAVAN.
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