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www.fdanews.com/articles/198692-tricida-hit-with-crl-for-chronic-kidney-disease-drug

Tricida Hit With CRL for Chronic Kidney Disease Drug

August 25, 2020

The FDA has turned down Tricida’s new drug application for veverimer, which treats metabolic acidosis in patients with chronic kidney disease, and said it needs to see more supporting data.

In a Complete Response Letter (CRL), the agency called for more data on the drug’s effect and questioned whether the effect would be “reasonably likely to predict clinical benefit.”

Tricida said the agency raised no safety, pharmacology or nonclinical issues in the CRL.

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