CDER Proposes to Withdraw Approval of Tavneos

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April 27, 2026 -- Today, the Center for Drug Evaluation and Research (CDER) proposed that Tavneos (avacopan) be withdrawn from the market because new information indicates that Tavneos has not been shown to be effective for its approved use, and because the application that resulted in FDA approval contained untrue statements of material fact. Once this proposal is published in the Federal Register, this webpage will be updated with a link to the docket where interested persons may view supporting materials and submit comments.

Tavneos was approved on October 7, 2021, and is used together with glucocorticoids and other standard-of-care medications to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), a group of rare diseases that cause inflammation in small-to-medium-sized blood vessels. Tavneos does not eliminate glucocorticoid use.

As explained in the proposal to withdraw approval of Tavneos, new information that only became known to CDER more than three years after approval shows that unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion. The applicant also did not disclose the original analysis to FDA, in violation of FDA regulations. CDER can no longer conclude that there is, or has ever been, a valid demonstration that Tavneos is effective for its approved use. Therefore, CDER has proposed that Tavneos be withdrawn from the market and has issued a notice of opportunity for a hearing (NOOH) to the application holder of Tavneos, ChemoCentryx Inc., a wholly owned subsidiary of Amgen, Inc.

Additionally, CDER is increasingly concerned about the safety profile of Tavneos. As further detailed in a March 31, 2026, drug safety communication, CDER has identified cases of serious drug-induced liver injury (DILI) associated with Tavneos. Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns.

Tavneos will remain on the market until the applicant decides to remove the drug or the FDA Commissioner mandates its removal. If the applicant requests a hearing, the FDA Commissioner will determine whether to hold a public hearing and, following such hearing, decide whether to withdraw approval of Tavneos.

In the interim, we recommend that health care professionals discuss Tavneos and other available treatments with their patients to decide whether to use or continue to use Tavneos while a final decision is being made about the drug’s marketing status.

Source: FDA

Source: HealthDay

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  • FDA Approves Tavneos (avacopan) for the Adjunctive Treatment of ANCA-Associated Vasculitis - October 8, 2021
  • ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis - July 9, 2020

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    Posted : 2026-04-28 15:19

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