Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19


The EMA’s CHMP has granted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with sev. renal impairment, incl. those on dialysis
The positive opinion was based on the results from a P-I PK study (GS-US-540-9015) as well as results from the P-III trial (REDPINE) evaluating the safety of Veklury in a ratio (2:1) in 243 hospitalized adult patients hospitalized with COVID-19 with sev. renal impairment. In both trials, no new safety signals and no additional adverse reactions to Veklury were observed
If Veklury was granted by the EC, it will become the first authorized antiviral treatment across all stages of renal disease. Veklury was approved in 50+ countries globally

Ref: Gilead | Image: Gilead

Related News:- Gilead’s Veklury (remdesivir) Receives WHO’s Recommendation for the Treatment of COVID-19

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