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Gilead Receives the US FDA Approval for Veklury's (remdesivir) sNDA to Treat COVID-19 in Pediatric Patients Aged ≥12 Years

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Gilead Receives the US FDA Approval for Veklury's (remdesivir) sNDA to Treat COVID-19 in Pediatric Patients Aged ≥12 Years

Gilead Receives the US FDA Approval for Veklury's (remdesivir) sNDA to Treat COVID-19 in Pediatric Patients Aged ≥12 Years

Shots: 

  • 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 

Click here to­ read the full press release 

Neha

Neha Madan is a content writer at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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