- 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.
