Tricida (TCDA) Says FDA Accepts Veverimer NDA

Tricida, Inc. (Nasdaq: TCDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for veverimer under the Accelerated Approval Program. In its correspondence, FDA also stated that no filing review issues were identified. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 22, 2020 and indicated that it is currently planning to hold a Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the application.

The NDA submission is supported by data from Tricida’s successful Phase 3 clinical trials that were recently published in back-to-back publications in The Lancet (March 2019 and June 2019).

“We are pleased that our application for veverimer was accepted for review under the Accelerated Approval Program and look forward to engaging with experts at an advisory committee meeting,” said Gerrit Klaerner, Ph.D., Tricida’s chief executive officer and president. “With a potential approval in August 2020, veverimer would be the first and only FDA-approved therapy for the chronic treatment of metabolic acidosis in patients with CKD. Our commercial team is targeting a successful launch with a full quarter of revenue in the fourth quarter of 2020.”

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