EU regulator recommends extending Gilead’s COVID treatment Veklury for use in pediatric patients


Gilead Sciences Inc. GILD, +0.92% said Friday the European regulator has adopted a positive opinion on extending the use of its COVID treatment Veklury for pediatric patients. The European Commission will review the recommendation, and if adopted, Veklury, also called remdesivir, could become the only authorized treatment for adolescents at high risk of developing severe disease and children with COVID who require supplemental oxygen. The positive opinion was based on a Phase 2/3 trial of Veklury among pediatric patients hospitalized with COVID, with a high proportion of participants showing clinical improvement and recovery, as well as date from trials involving adult patients. The news comes after the World Health Organization expanded its recommended guide for the use of Veklury to treat patients with severe COVID, an expansion from simply “those with non-severe COVID-19 at the highest risk of hospitalization.” Gilead shares were down 0.8% premarket, and have fallen 10% in the year to date, while the S&P 500 SPX, -0.72% has fallen 18%.

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