FDA rejects Tricida’s veverimer for metabolic acidosis in CKD patients

Tricida (TCDA -14.5%) has received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval of veverimer (TRC101) for metabolic acidosis in patients with chronic kidney disease (CKD).

The application was reviewed under the Accelerated Approval Program.

The CRL cited the need of additional data beyond the TRCA-301 and TRCA-301E trials, regarding the magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate.

FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit

The company plans to request a Type A meeting with the FDA in the coming weeks

Last month, the FDA flagged deficiencies in veverimer.

https://seekingalpha.com/news/3608218-fda-rejects-tricidas-veverimer-for-metabolic-acidosis-in-ckd-patients