Gilead Receives the US FDA’s Approval of Veklury (remdesivir) sNDA for the Treatment of COVID-19 in Patients with Severe Renal Impairment
- The US FDA has approved an sNDA for the use of Veklury in COVID-19 patients with severe renal impairment, incl. those on dialysis
- The approval was based on the results from a P-I study (GS-US-540-9015) evaluating Veklury in a ratio (2:1) in 243 hospitalized adult patients as well as results from the P-III trial (REDPINE) trial. The results showed the PK and safety profile of Veklury with no new safety signals
- Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients in the US who are either hospitalized or not hospitalized and are at high risk for progression to sev. COVID-19, incl. hospitalization or death
Ref: Businesswire | Image: Gilead
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