Gilead Receives the US FDA Approval for Veklury's (remdesivir) sNDA to Treat COVID-19 in Pediatric Patients Aged ≥12 Years
- The approval was based on the P-II/III (CARAVAN) study evaluating Veklury in 53 pediatric patients aged ≤12yrs. with COVID-19 who are at high risk for progression to sev. COVID-19 includes hospitalization or death
- The results showed that the therapy was found to be well-tolerated, a high proportion of patients showed clinical improvement & recovery, 75% & 85% clinical improvement @Day 10 & last assessment while 60% & 83% were discharged by Day 10 & 30, respectively with no new safety signals, 72% experienced AEs with 21% SAEs
- Veklury has been approved in the US for COVID-19 in pediatric patients & was approved or authorized for temporary use in ~50 countries globally
Ref: Gilead | Image: Gilead
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