The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Tricida regarding its New Drug Application (NDA) for veverimer 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 included data from two phase 3 trials (TRCA-301 and TRCA-301E) that evaluated the efficacy and safety of veverimer.
In the CRL, the FDA identified deficiencies in the application and requested “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 US population.” There were also concerns as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit. No safety issues were noted in the letter.
The Company plans to request a Type A meeting with the FDA in the coming weeks to discuss options on the next steps for an NDA resubmission.
“We have collaborated with the FDA on the Accelerated Approval Program for veverimer and while we are disappointed to receive this CRL, we are pleased that the FDA has provided helpful, specific comments and indicated their willingness to continue to work with us to pursue approval of veverimer,” said Gerrit Klaerner, PhD, Tricida’s CEO and President. “We remain confident in the fundamentals of, and unmet medical need for, veverimer and we continue to conduct our confirmatory trial, VALOR-CKD.”
The VALOR-CKD study is a double-blind, placebo-controlled trial (n=1600) evaluating the effect of veverimer on the progression of chronic kidney disease in patients with metabolic acidosis; the average duration of follow up is expected to be 3.5 years.
For more information visit tricida.com.
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. https://www.businesswire.com/news/home/20200824005200/en/Tricida-Receives-Complete-Response-Letter-FDA-New. Accessed August 24, 2020.