Posted by Michael Wonder on 24 Aug 2020
Tricida receives complete response letter from the FDA for its new drug application for veverimer for the treatment of metabolic acidosis and slowing of kidney disease progression in patients with metabolic acidosis associated with CKD
24 August 2020 - Tricida announced today that it received a complete response letter from the U.S. FDA for its new drug application for veverimer on 21 August 2020.
The application was reviewed under the accelerated approval program.
According to the complete response letter, the FDA is seeking 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 and the applicability of the treatment effect to the U.S. population. the FDA also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit.
