Tricida will meet with the FDA in an attempt to provide more data for the treatment of patients with chronic kidney disease.
The US Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) for veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease.
Tricida confirmed the CRL for their New Drug Application (NDA) reviewed under the FDA’s Accelerated Approval Program on Aug. 21.
The FDA is requesting additional data beyond the results of 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.
The agency also expressed concern about whether the demonstrated effect size would be reasonably likely to predict clinical benefit.
The CRL also states there were no safety, clinical pharmacology/biopharmaceutics, CMC, or non-clinical issues identified.
The FDA provided multiple options for the pharmaceutical company to resolve the identified deficiencies, including conducting an additional clinical trial.
Tricida announced plans to request a Type A meeting with the FDA in the coming weeks, which is usually scheduled within 30 days of the request.
“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,” Gerrit Klaerner, PhD, Tricida’s Chief Executive Officer and President, said in a statement. “We remain confident in the fundamentals of, and unmet medical need for, veverimer and we continue to conduct our confirmatory trial, VALOR-CKD.”