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