Tavneos Drug Label Change By Amgen Just 2 Days After Tavneos Drug Recall Statement By FDA

(Posted by Tom Lamb at Drug Injury Watch)

The Tavneos drug safety issue has an interesting new development. On April 29, 2026, Amgen submitted to the FDA a Tavneos drug label change to strengthen warnings for the vanishing bile duct syndrome (VBDS) Tavneos liver side effect. This Amgen action came just two days after the FDA announced it was considering a Tavneos drug recall due to unusual circumstances related to the drug’s approval in October 2021.

We begin our coverage with an overview of the Tavneos drug safety issue provided by this May 1, 2026, EndpointNews report, “Amgen files update to Tavneos label as FDA escalates push to withdraw“:

Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA.

The company filed a supplement on Wednesday that would add more information to the warning label about post-market cases of vanishing bile duct syndrome (VBDS), a serious liver complication that can lead to death. The supplement, disclosed in Amgen’s first-quarter earnings release, marks another twist in the company’s ongoing saga with regulators over Tavneos’ future on the market.

Tavneos was approved in 2021 to treat a rare autoimmune disease called ANCA-associated vasculitis. Amgen scooped it up the following year in its $4 billion acquisition of ChemoCentryx.

The FDA asked Amgen to pull Tavneos from the market voluntarily at the beginning of this year.

[The FDA’s Center for Drug Evaluation and Research (CDER)] reiterated its push in a proposal to withdraw the drug earlier this week, citing new information that it says suggests Tavneos “has not shown to be effective for its approved use,” and that its marketing application held “untrue statements of material fact.” The FDA accused study personnel of manipulating the results of a pivotal clinical trial used to approve the drug.

Regulators also said they were “increasingly concerned” about the drug’s safety.

Given that background information, we now direct you to some “source material” relevant to the situation of a Tavneos drug label change closely followed by an FDA announcement about a possible Tavneos drug recall, which has become the latest twist to this Tavneos drug safety issue.

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First, from an April 30, 2026, Amgen News Release, “AMGEN REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS“, the following points were excerpted from pages 9-10:

•On April 27, 2026, FDA’s Center for Drug Evaluation and Research (CDER) issued a proposal to withdraw approval of TAVNEOS, asserting that there is new information indicating lack of substantial evidence of effectiveness for the drug and that ChemoCentryx’s application that resulted in FDA approval contained untrue statements of material facts.
•On April 30, 2026, the FDA posted a notice in the Federal Register that proposes to withdraw approval of TAVNEOS and announced an opportunity for ChemoCentryx, as the U.S. marketing authorization holder, to request a hearing on this proposal.
•As such, ChemoCentryx may request a hearing on this proposal,…
•The current U.S. label includes a warning about hepatotoxicity and guidance for monitoring patients. The [March 31, 2026, FDA] Drug Safety Communication provides additional information about drug-induced liver injury and vanishing bile duct syndrome (VBDS) associated with TAVNEOS….
•On April 29, 2026, the Company submitted a Changes Being Effected (CBE-30) supplement to the FDA. The CBE-30 filing amends the hepatotoxicity warning language in the label to provide more information on cases of VBDS that have been observed in the post-marketing setting, including that cases with fatal outcomes have been reported, and modifies language regarding liver panel testing and treatment discontinuation rules.

Next, we turn to this April 27, 2026, FDA Drug Alerts and Statements document, “CDER proposes to withdraw approval of TAVNEOS“, which presents some important contextual information:

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.

Lastly, from this April 28, 2026, MedPage Today piece, “FDA Claims ‘Manipulated’ Data Led to Drug’s Approval, Proposes Withdrawal — Pivotal trial on [Tavneos (avacopan)] was negative before actions of unblinded study personnel, agency says“:

In a Monday letter to Amgen, which now holds [Tavneos (avacopan)’s] rights, the agency’s top drug regulator said that new information came to light showing [Tavneos (avacopan)] lacks “substantial evidence of effectiveness,” and that developer ChemoCentryx’s new drug application (NDA) contained “untrue statements of material facts” — both legal bases for pulling a drug.

Unblinded study personnel “manipulated” primary endpoint results for the pivotal ADVOCATE study, said Tracy Beth Høeg, MD, PhD, acting director of the Center for Drug Evaluation and Research.

“That manipulation was designed to change results that were not statistically significant and make the product look effective when the original analysis did not support that conclusion,” she wrote in the letter. “If the data as originally analyzed according to the prespecified statistical analysis plan had been submitted to the agency, the study would not have been viewed as establishing substantial evidence of effectiveness, which is a legal requirement for approval of an NDA….

Høeg’s letter also cited concerns about [Tavneso (avacopan] over liver safety.

Here are two recent Drug Injury Watch articles concerning the Tavneos drug safety issue:

Tavneos Liver Injury Drug Safety Communication Issued by FDA in Late March 2026 (March 31, 2026)

Tavneos Lawsuits for Drug Injury After Possible Tavneos Recall (April 17, 2026)

We are investigating drug injury lawsuits involving Tavneos drug-induced liver injury (DILI) and Tavneos vanishing bile duct syndrome (VBDS). If you or someone you know was diagnosed with DILI or VBDS liver-related side effects, you can submit a Drug Injury Case Evaluation Form online, send an email to drug injury lawyer Tom Lamb at TJL@LambLawOffice.com, or call us at 910-256-2971.

We will continue to monitor the ongoing Tavneos drug safety issue, including this April 2026 Tavneos drug label change filing by Amgen, as well as the possible FDA Tavneos drug recall, and report further developments here at Drug Injury Watch.

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