Complete Response in Tricida Metabolic Acidosis NDA

FDA has issued Tricida a complete response letter on its NDA for veverimer, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. The letter requested additional data beyond the TRCA-301 and TRCA-301E trials involving 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 company says. The agency also expressed concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit, it says, adding that there were no safety, clinical pharmacology/biopharmaceutics, chemistry, manufacturing and controls, or non-clinical issues identified. Tricida says it plans to request a Type A meeting with FDA in the coming weeks to better understand the data request.