Federal Register #FDA2026N1321

FDA Proposes Withdrawal of TAVNEOS (Avacopan) Capsule, 10 mg Approval

This notice details the FDA's proposal to withdraw approval of TAVNEOS (avacopan) capsule, 10 mg, manufactured by ChemoCentryx, Inc.: - Government Buyer: - Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) - OEM and Vendor: - ChemoCentryx, Inc. (manufacturer and NDA holder) - Product Referenced: - TAVNEOS (avacopan) capsule, 10 mg - Part number: NDA 214487 - Indication: Adjunctive treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy - Notable Requirements and Issues: - FDA cites data manipulation in the pivotal ADVOCATE study, specifically alteration of primary endpoint results post-unblinding - Presence of untrue statements of material fact in the NDA - Serious safety risks identified, including hepatotoxicity and vanishing bile duct syndrome - ChemoCentryx, Inc. is offered an opportunity to request a hearing and submit supporting data before withdrawal - No procurement or award is being made; this is a regulatory action regarding drug approval status

Description

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of the new drug application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams, held by ChemoCentryx, Inc. The proposal is based on two grounds: lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its labeling, and the application contains untrue statements of material fact. The notice provides an opportunity for the applicant to request a hearing and submit supporting data, information, and analyses by specified deadlines. Comments from other interested parties are also invited.

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