Gilead Receives the US FDA’s Approval of Veklury (remdesivir) sNDA for the Treatment of COVID-19 in Patients with Severe Renal Impairment
Shots:
- 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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Neha is a Senior Editor 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. She can be contacted at connect@pharmashots.com.
