FDA Approves Remdesivir in Kidney Patients after Failed Trial
Action added to Long List of Pandemic Regulatory Malfeasance
By Peter A. McCullough, MD, MPH
In a move that defies all regulatory convention, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease but has no efficacy data to support its administration.
July 14, 2023
FDA Approves Veklury® (Remdesivir) for COVID-19
Treatment in Patients With Severe Renal Impairment,
Including Those on Dialysis
– Veklury is Now the First Approved Antiviral Treatment for Patients
Across all Stages of Renal Disease —
FOSTER CITY, Calif.-(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq:
GILD) today announced that the U.S. Food and Drug Administration
(FDA) approved a supplemental new drug application (sNDA) for the
use of Veklury® (remdesivir) in COVID-19 patients with severe renal
impairment, including those on dialysis. With this approval, Veklury is
now the first and only approved antiviral COVID-19 treatment that can
be used across all stages of renal disease. More than 1 in 7 (37 million)
people in the U.S. are estimated to have chronic kidney disease (CKD)
and are at increased risk of COVID-19 related morbidity and mortality.
The U.S. approval comes on the heels of the European Commission
decision to extend the approved use of Veklury to treat COVID-19 in
people with severe renal impairment, including those on dialysis, which
was adopted on June 26 2023
About GS-US-540-5912 (REDPINE)
Gilead conducted a Phase 3, randomized, double-blind, placebo-
controlled, parallel-group, multicenter study (REDPINE) evaluating the
efficacy and safety of Veklury in patients with severely reduced kidney
function who are hospitalized with COVID-19. The trial enrolled 243
hospitalized adult participants with confirmed COVID-19 and renal
impairment who were randomized in a 2:1 manner to receive Veklury
(n=163) or placebo (n=80), in addition to standard of care, and were
stratified by ESKD, high-flow oxygen requirement, and region (US vs.
ex-US). The study closed prematurely due to feasibility issues and was
underpowered to assess for efficacy because of lower-than-expected
enrollment. No new safety signals were observed in the study and no
additional adverse reactions to Veklury were identified in 163
hospitalized patients with confirmed COVID-19 and acute kidney iniurv
(AKI) (n=60), CKD (eGFR <30 mL/minute) (n=44) or ESKD (eGFR <15
mL/minute) requiring hemodialysis (n=59) receiving Veklury for up to 5
days.
The phase 3 REDPINE trial failed to recruit sufficient subjects to assess efficacy. Instead of properly rejecting the application, the FDA went ahead and approved the drug with insufficient safety and efficacy data. The drug has struggled in recent years as patients commonly decline the antiviral since the November, 2020, WHO warning against inpatient use. Remdesivir can cause both kidney injury and liver damage, thus with no mortality benefit, many believe it should not be used.
