The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for veverimer (TRC101; Tricida) for the treatment of metabolic acidosis in patients with chronic kidney disease (CKD).
Veverimer is a novel, non-absorbed polymer that works by binding to hydrochloric acid in the gastrointestinal tract and removing it from the body through excretion in the feces. The NDA submission was supported by data from two phase 3 trials (TRCA-301 and TRCA-301E) that evaluated the efficacy and safety of veverimer. TRCA-301 was a 12-week, double-blind, placebo-controlled trial in 217 patients with CKD and metabolic acidosis, which was followed by a 40-week, blinded, placebo-controlled TRCA-301E safety extension trial that included 196 patients who completed TRCA-301.
The composite primary end point of TRCA-301 was the difference in the proportion of patients achieving either an increase of ≥4mmol/L from baseline in serum bicarbonate concentration or serum bicarbonate in the normal range (22–29mmol/L) at Week 12. Results showed 59% of veverimer-treated patients met the composite primary end point compared with 22% in the placebo group (difference: 37%; 95% CI 23-49; P <.0001).
Regarding safety, TRCA-301E showed fewer patients on veverimer discontinued treatment prematurely vs placebo (3% vs 10%, respectively), along with having a lower frequency of serious adverse events (2% vs 5%, respectively). Moreover, veverimer-treated patients had a greater increase in bicarbonate at week 52 vs placebo (63% vs 38%, respectively; P =.0015) and at all timepoints starting at week 1 (P <.001). Veverimer also resulted in statistically significant improvements in patient-reported physical functioning and time to do the repeat chair stand test, compared with placebo.
“We are pleased that our application for veverimer was accepted for review under the Accelerated Approval Program and look forward to engaging with experts at an advisory committee meeting,” said Gerrit Klaerner, PhD, Tricida’s CEO and president. “With a potential approval in August 2020, veverimer would be the first and only FDA-approved therapy for the chronic treatment of metabolic acidosis in patients with CKD. Our commercial team is targeting a successful launch in the fourth quarter of 2020.”
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of August 22, 2020.
For more information visit tricida.com.