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Benzinga
Benzinga
Technology
Vandana Singh

Gilead's Remdesivir Becomes First Approved Treatment For Pediatric COVID-19 Patients

  • The FDA has approved Gilead Sciences Inc's (NASDAQ:GILD) supplemental marketing application for Veklury (remdesivir) for pediatric COVID-19 patients older than 28 days.
  • The approval covers patients weighing at least 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe infection.
  • This approval follows the recent FDA nod for Veklury for non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19.
  • Related: Gilead Shares Updated Data From Remdesivir Study In Pediatric COVID-19 Patients.
  • Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in high-risk non-hospitalized COVID-19 pediatric patients. 
  • For hospitalized pediatric patients who do not require invasive mechanical ventilation, a 5-day treatment course is recommended. 
  • The approval was supported by results from the CARAVAN Phase 2/3 study. Of the 53 pediatric patients, no new safety signals were apparent for patients treated with Veklury. 
  • Overall, 75% and 85% showed clinical improvement at Day 10 and the last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30. 
  • Price Action: GILD shares closed at $62.65 on Monday.
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