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Gilead Sciences Says CHMP Adopts Positive Opinion To Extend Indication Of Veklury

Gilead Sciences, Inc. (GILD) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 as well as pediatric patients (4 weeks of age and older and weighing at least 3 kg) 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 European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.

This positive opinion was based on results from the ongoing CARAVAN Phase 2/3 study, which demonstrated Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.

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