Tavneos on Formularies as FDA Moves to Withdraw: The Coverage Dilemma

When a pharmacy and therapeutics (P&T) committee meets in late 2026 to review formulary status for specialty immunosuppressive therapies, it faces an unprecedented regulatory situation: Tavneos (avacopan), ChemoCentryx/Amgen's complement 5a receptor (C5aR) antagonist approved as an adjunctive treatment for severe active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, is subject to an active FDA proceeding to withdraw marketing approval. Simultaneously, the European Commission issued a legally binding revocation of its European Union marketing authorization on August 4, 2026, and the New England Journal of Medicine (NEJM) retracted the pivotal Phase 3 ADVOCATE trial.

Yet, in the United States, Tavneos remains an FDA-approved, legally marketed prescription drug. National drug directories show active product listings, commercial and Medicare Part D formularies maintain active prior authorization (PA) guidelines, and patients remain on active therapy.

For health plan medical directors, pharmacy benefit managers (PBMs), specialty pharmacies, and rheumatology/nephrology practice managers, this creates a profound operational and clinical dilemma: Can or should a health plan remove Tavneos from its formulary mid-year, what legal and contractual obligations exist toward patients currently stable on therapy, and how should clinical access teams handle prior authorization criteria built on the very trial endpoint whose adjudication regulators now dispute?

This dossier analyzes the regulatory record behind the FDA withdrawal proceeding, verifies the drug's current marketing and dataset status, unpacks public adverse event surveillance data from openFDA FAERS, examines payer policy constraints, and provides an operational roadmap for market-access leaders.

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What exactly did FDA propose on April 27, 2026, and what has not happened yet?

On April 27, 2026, the FDA's Center for Drug Evaluation and Research (CDER) issued a formal Notice of Opportunity for a Hearing (NOOH) to ChemoCentryx, Inc. (acquired by Amgen in 2022) proposing to withdraw approval of New Drug Application (NDA) 214487 for Tavneos (avacopan) 10 mg oral capsules. The proposal was published in the Federal Register on April 30, 2026 (91 FR 23278, Document 2026-08455, Docket No. FDA-2026-N-1321).

The FDA's action was initiated under two specific statutory provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations under Title 21 of the Code of Federal Regulations (21 CFR Part 314):

1. Section 505(e)(3) and 21 CFR 314.150(a)(2)(iii): 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.
2. Section 505(e)(5) and 21 CFR 314.150(a)(2)(iv): Untrue statements of material fact in the application.

┌─────────────────────────────────────────────────────────────────────────┐
│              FDA Section 505(e) Withdrawal Pathway vs Reality           │
├─────────────────────────────────────────────────────────────────────────┤
│ 1. April 27, 2026: CDER issues Notice of Opportunity for Hearing (NOOH) │
│ 2. April 30, 2026: Published in Federal Register (91 FR 23278)          │
│ 3. 30-Day Window: Applicant files notice of participation & hearing req │
│ 4. 60-Day Window: Applicant submits data showing genuine issue of fact  │
│ 5. July 23, 2026: Amgen submits formal defense & comprehensive analyses │
│ ─────────────────────────────────────────────────────────────────────── │
│ CURRENT STATUS (August 2026):                                           │
│ • FDA Commissioner reviewing hearing threshold under 21 CFR 314.200     │
│ • Tavneos REMAINS APPROVED and LEGALLY MARKETED in the United States    │
│ • No final withdrawal order has been issued                             │
└─────────────────────────────────────────────────────────────────────────┘

The underlying basis of CDER's notice centers on an inspection and data audit of the pivotal Phase 3 ADVOCATE trial (NCT02994927), which the notice states "randomized 331 subjects with AAV to avacopan 30 mg twice daily or a protocol-specified prednisone taper in a 1:1 ratio" alongside standard induction therapy, in granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

The specific finding matters more than the general characterization. FDA's notice states that five avacopan patients' primary endpoint assessments were readjudicated from "not in sustained remission" to "sustained remission" following database unblinding. The NEJM retraction notice, requested by the two academic authors, describes nine patients whose primary endpoint assessments were re-adjudicated after database lock and after unblinding. Those are small counts against 331 randomized subjects — but the primary efficacy endpoint was sustained remission at Week 52 measured by the Birmingham Vasculitis Activity Score (BVAS), and a handful of reclassified responders is enough to move a narrow superiority result. That is the mechanism payers should understand, rather than a vague impression that "the data were faked."

What Has Not Happened

Crucially for payers and prescribers, CDER's notice is a proposal to withdraw, not a summary revocation:

• No Final Agency Action: Under 21 CFR 314.200, the sponsor has procedural due process rights. ChemoCentryx/Amgen filed a timely request for a hearing.
• Amgen's Active Defense: On July 23, 2026, Amgen submitted extensive data, re-analyses, and clinical arguments to the FDA in support of its hearing request, asserting that the totality of clinical data from ADVOCATE and real-world clinical experience meets the statutory standard for substantial evidence of effectiveness and maintains a favorable benefit-risk profile.
• Product Remains on the Market: In an explicit statement published on its alert page, the FDA clarified: "TAVNEOS will remain on the market until the applicant decides to remove the drug or the FDA Commissioner mandates its removal." If the Commissioner determines that the applicant has raised a genuine and substantial issue of fact, a formal administrative hearing will be held before any final order is issued.

Understanding this procedural distinction is essential. When analyzing pre-market non-approvals, access teams often evaluate CMC-only complete response letters, where a product never reached the commercial channel. In stark contrast, Tavneos has been commercially available since October 2021, so any plan covering ANCA-associated vasculitis is likely to have members already established on therapy under an existing authorization.

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Is Tavneos still FDA-approved and legally marketed in the United States today?

To verify the exact regulatory and marketing reality beyond corporate press releases and trade commentary, we audited official FDA and CMS master databases as of August 2026.

The regulatory data establish that NDA 214487 maintains full legal standing under federal law. The package codes NDC 73556-168-01 (180-capsule bottle), 73556-168-02 (30-capsule bottle), and 73556-168-96 (a second 30-capsule bottle configuration) all carry a 2021-10-18 marketing start date and no marketing end date, and remain valid for electronic claim submission, real-time adjudication, and specialty pharmacy fulfillment.

Furthermore, because NDA 214487 is active, Tavneos continues to satisfy the statutory definition of a Covered Outpatient Drug under Section 1927(k) of the Social Security Act for Medicaid and a Covered Part D Drug under 42 CFR § 423.100 for Medicare Part D.

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Why does the European Commission revocation not change US coverage obligations?

The divergence between European and American regulatory outcomes has created significant confusion among US clinical committees.

The EMA referral page records a CHMP opinion date of 25 June 2026, on which the European Medicines Agency's Committee for Medicinal Products for Human Use concluded an Article 20 non-pharmacovigilance referral procedure; EMA's public news item announcing the recommendation is dated 26 June 2026, which is why both dates circulate in trade coverage. The CHMP concluded that the ADVOCATE trial was conducted in breach of GCP principles and that the data submitted at authorization were unreliable. Following that opinion, the European Commission adopted a legally binding decision on August 4, 2026, revoking the marketing authorization for Tavneos across all EU and European Economic Area (EEA) member states. Marketing authorization holder Vifor Fresenius Medical Care Renal Pharma (CSL Vifor) formally confirmed on August 6, 2026, that the product was withdrawn from European commercial distribution.

┌────────────────────────────────────────────────────────────────────────┐
│             US vs. EU Regulatory Mechanisms for Tavneos                │
├──────────────────────────────────┬─────────────────────────────────────┤
│ European Union (EMA / EC)        │ United States (FDA / CDER)          │
├──────────────────────────────────┼─────────────────────────────────────┤
│ • Authority: Article 20 Referral │ • Authority: FD&C Act Section 505(e)│
│ • Standard: Precautionary / GCP  │ • Standard: 21 CFR 314.200 Hearing  │
│ • Decision: Revocation adopted   │ • Decision: Proposed withdrawal     │
│   on August 4, 2026              │   pending hearing determination     │
│ • Legal Effect: Binding in EU;   │ • Legal Effect: Zero direct impact  │
│   commercial supply terminated   │   on US NDA or FDA marketing status │
│ • Commercial Status: Withdrawn   │ • Commercial Status: Legally active │
└──────────────────────────────────┴─────────────────────────────────────┘

Why does the European revocation not automatically dictate US policy?

1. Jurisdictional Independence: FDA regulatory actions are governed strictly by the FD&C Act and the Administrative Procedure Act (APA). An action by the European Commission, Swissmedic, or any other foreign authority has no direct statutory force in the United States.
2. Standard of Review: Unlike expedited subpart H or Accelerated Approval withdrawals—which we track in our postmarketing requirement tracker—Tavneos was approved under standard NDA review pathways (Type 1 New Molecular Entity, standard review). Standard approvals require full evidentiary hearings under Section 505(e) unless waived by the applicant.
3. Payer Contract Law: Commercial payer contracts, ERISA plan documents, and CMS Medicare Part D regulations bind coverage to FDA approval status, compendia listings, and medical necessity. An EU revocation provides contextual evidence of regulatory risk, but it does not relieve a US health plan of its standard coverage adjudication rules.

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What does FDA's safety case actually say, and what do the public FAERS data show about where those cases came from?

Beyond the efficacy data manipulation allegations, CDER's notice of opportunity for a hearing highlighted a significant post-marketing hepatic safety signal. Understanding the specifics of this safety case—and cross-referencing it against public pharmacovigilance data—is critical for P&T committees evaluating patient risk.

The FDA's Causality-Assessed Case Series

In the April 27, 2026 notice, CDER reported findings from an integrated safety analysis conducted by the Office of Surveillance and Epidemiology (OSE). Reviewing the applicant's global safety database, published medical literature, and the FDA Adverse Event Reporting System (FAERS) through October 9, 2024, CDER identified:

• 76 Cases of Drug-Induced Liver Injury (DILI): Evaluated as causally associated with avacopan (72 assessed as possibly causally related; 4 assessed as probably causally related).
• 7 Cases of Biopsy-Confirmed Vanishing Bile Duct Syndrome (VBDS): A rare, severe, and potentially irreversible cholestatic liver injury characterized by progressive destruction and loss of intrahepatic bile ducts.
• 74 Serious Outcomes: Including 54 hospitalizations and 8 deaths.

Independent Audit of the openFDA FAERS Database

To independently evaluate the characteristics and geographic origin of avacopan adverse event reports, we analyzed the complete openFDA FAERS dataset (snapshot 20260610, export date 2026-06-08, capturing reports received from 2021 through Q1 2026).

Total Deduplicated FAERS Reports Naming Avacopan / Tavneos (2021–2026): 5,695
├── Serious Reports: 4,025 (70.7%)
├── Reports with Death Flagged: 581 (10.2%)
├── Hepatic / Liver / Biliary / Cholestatic Reaction Terms: 586 (10.3%)
└── Vanishing Bile Duct Syndrome (VBDS) Exact Term: 44 (0.8%)

When we stratify these adverse event reports by country of occurrence (occurcountry), a striking geographic pattern emerges:

┌──────────────────────────────────────────────────────────────────────┐
│          Geographic Stratification of Avacopan FAERS Cohort          │
├─────────────────────────┬───────────────┬───────────────┬────────────┤
│ Country of Occurrence   │ All Reports   │ Hepatic Terms │ VBDS Terms │
├─────────────────────────┼───────────────┼───────────────┼────────────┤
│ Total                   │ 5,695         │ 586           │ 44         │
│ Japan                   │ 832 (14.6%)   │ 345 (58.9%)   │ 42 (95.5%) │
│ United States           │ 2,339 (41.1%) │ 112 (19.1%)   │ 0 (0.0%)   │
│ United Kingdom + Europe │ 539 (9.5%)    │ 68 (11.6%)    │ 0 (0.0%)   │
│ Canada                  │ 312 (5.5%)    │ 12 (2.0%)     │ 2 (4.5%)   │
│ All other countries     │ 58 (1.0%)     │ 12 (2.0%)     │ 0 (0.0%)   │
│ Country Not Stated      │ 1,615 (28.4%) │ 37 (6.3%)     │ 0 (0.0%)   │
└─────────────────────────┴───────────────┴───────────────┴────────────┘

Columns sum to the stated totals. "United Kingdom + Europe" aggregates every European country code plus the non-specific EU code that openFDA carries for some reports; within the hepatic subset it is composed of EU 23, France 20, United Kingdom 9, Germany 6, Switzerland 6, and one report each from Belgium, Luxembourg, Greece, and Spain.

Hepatic Term Reports (N=586)
Japan:          ██████████████████████████████ 345 (58.9%)
United States:  ██████████ 112 (19.1%)
UK + Europe:    ██████ 68 (11.6%)
Not Stated:     ███ 37 (6.3%)
Canada:         █ 12 (2.0%)
Other:          █ 12 (2.0%)

Vanishing Bile Duct Syndrome Reports (N=44)
Japan:          ████████████████████████████████████████ 42 (95.5%)
Canada:         ██ 2 (4.5%)
United States:  0 (0.0%)

Critical Methodological Limitations

Access and clinical teams reviewing these data must apply the principles outlined in our guide on how to read an FDA FAERS report:

1. Spontaneous Reports Do Not Establish Incidence or Causality: Raw FAERS report counts represent spontaneous reporting, not a controlled clinical trial. They lack a defined denominator of total treated patients.
2. Reporting Skew Is a Confound, Not an Explanation: The concentration of hepatic and VBDS reports from Japan (345 of 586 hepatic reports; 42 of 44 VBDS reports) sits far above Japan's 14.6% share of the overall cohort, and reporting-system differences are the first thing to suspect: Japan's post-marketing surveillance obligations and early post-approval intensive monitoring generate reports at rates that are not comparable to US spontaneous reporting. But the data cannot adjudicate between a reporting artifact and a real population difference, and it is worth noting that the US label already prescribes a separate, more frequent liver-monitoring schedule for patients of Japanese descent. Do not read this table as establishing either that Japanese patients are at higher biological risk or that they are not. Missing country data compounds this: 1,615 of 5,695 reports (28.4%) carry no country of occurrence, so every geographic share here is a share of an incompletely labelled cohort.
3. FDA Case Series vs. FAERS Text Queries: The two numbers are not comparable and neither is a subset of the other. FDA's 76 cases come from a causality-assessed review spanning the sponsor's global safety database, the published literature, and FAERS through October 9, 2024; the notice does not disclose which causality instrument was applied. Our 586 is a reproducible text match: reports naming avacopan or Tavneos in the substance or brand field in any drug role, deduplicated on report ID, whose reaction terms match hepat, liver, bile duct, jaundice, transaminase, or cholestas. That pattern deliberately casts wide — it captures isolated transaminase elevations alongside serious injury — so it overcounts clinically meaningful hepatotoxicity while FDA's adjudicated series undercounts total hepatic signal.

For deeper insights into modern surveillance infrastructure, see our analysis of FDA's Adverse Event Monitoring System.

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How should a P&T committee handle prior-authorization criteria built on a retracted trial's endpoint?

The most immediate operational challenge for US health plans is not legal marketing status, but the internal architecture of their own clinical coverage policies.

A survey of published 2026 commercial and Medicare Advantage prior authorization policies (including UnitedHealthcare Program Document 2026 P 1377-5, Blue Cross Blue Shield, and regional health plans) reveals that existing criteria were adopted prior to the FDA's April 2026 notice:

┌────────────────────────────────────────────────────────────────────────┐
│           Typical Commercial Prior Authorization Policy Structure      │
├────────────────────────────────────────────────────────────────────────┤
│ Initial Approval Criteria (Standard 6-month or 12-month approval):     │
│ 1. Age ≥ 18 years;                                                     │
│ 2. Confirmed diagnosis of severe active GPA or MPA;                    │
│ 3. Positive test for anti-PR3 or anti-MPO antibodies;                  │
│ 4. Prescribed in combination with standard induction immunosuppressive │
│    therapy (rituximab or cyclophosphamide) AND systemic glucocorticoids│
│ 5. Baseline liver enzymes (ALT, AST, total bilirubin) within limits.   │
├────────────────────────────────────────────────────────────────────────┤
│ Reauthorization / Continuation Criteria:                               │
│ 1. Documentation of positive clinical response or disease remission    │
│    measured by the Birmingham Vasculitis Activity Score (BVAS = 0);    │
│ 2. Documented reduction or discontinuation of glucocorticoid dose;     │
│ 3. Absence of severe treatment-related hepatotoxicity (ALT/AST < 3x ULN│
│    or total bilirubin < 2x ULN).                                       │
└────────────────────────────────────────────────────────────────────────┘

The Reauthorization Problem

The core dilemma lies in the continuation criteria. Most payer policies explicitly condition renewal on "documented improvement or remission based on the Birmingham Vasculitis Activity Score (BVAS)."

Because the FDA notice and the NEJM retraction both rest on post-unblinding re-adjudication of exactly this endpoint, asking prescribers to submit BVAS forms creates clinical and administrative contradictions. Note the precise scope of the finding: neither document says the BVAS instrument itself is invalid, and BVAS remains a standard vasculitis disease-activity measure in clinical practice. What is contested is the sponsor's endpoint adjudication in one trial.

1. Endpoint Repudiation: Requiring a physician to prove efficacy using the same endpoint construct whose adjudication federal regulators have called into question creates friction and potential vulnerability during appeals.
2. Clinical Glucocorticoid Sparing: In clinical practice, the primary reason specialists prescribe avacopan is to minimize glucocorticoid-related toxicity (infections, bone loss, diabetes, cardiovascular events). Prescribers assess real-world benefit by the patient's ability to taper prednisone while maintaining clinical stability—not necessarily by formal BVAS calculations.

Recommended P&T Policy Adjustments

Health plans reviewing Tavneos should not abruptly terminate coverage for stable patients, but they should update their policy language to reflect clinical reality, applying best practices for documenting continued benefit at renewal:

• Update Reauthorization Standards: Transition continuation criteria away from mandatory BVAS score submissions toward comprehensive clinical stabilization documentation (e.g., stabilization of estimated GFR, absence of active urinary sediment, reduction in daily oral prednisone-equivalent dose to ≤ 5 mg/day).
• Reinforce Hepatic Safety Monitoring: Tavneos carries no boxed warning; hepatotoxicity sits in Warnings and Precautions. Align policy requirements with what that section actually directs: a liver test panel (ALT, AST, alkaline phosphatase, and total bilirubin) before initiating therapy, then every 4 weeks for the first 6 months and as clinically indicated thereafter.
• Apply the Label's Separate Japanese-Descent Schedule: The approved labeling specifies a distinct, more intensive schedule for patients of Japanese descent — testing every 2 weeks for the first 3 months, then every 4 weeks for the next 3 months. Plans whose PA templates carry only the general 4-week interval are out of step with the label for that population, and the FAERS geography above is a reason to check whether the plan's criteria and its specialty pharmacy's monitoring prompts reflect this.
• Explicit Discontinuation Criteria: Mirror the label rather than paraphrasing it. It directs discontinuation if AST or ALT exceeds 5 times the upper limit of normal; if ALT or AST exceeds 3 times ULN together with total bilirubin above 2 times ULN; if alkaline phosphatase reaches 2 times ULN or more; or if the patient develops clinical symptoms such as jaundice or pruritus. A transaminase elevation above 3 times ULN alone calls for prompt evaluation and consideration of pausing treatment, not automatic discontinuation.

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What breaks operationally if FDA does withdraw approval mid-plan-year?

If the FDA Commissioner ultimately denies Amgen's hearing request or if a formal hearing concludes with a final withdrawal order, the operational impacts across the pharmaceutical supply chain and payer administration will be swift and disruptive.

┌─────────────────────────────────────────────────────────────────────────┐
│              Supply Chain and Access Impacts of Final Withdrawal        │
├──────────────────────────────────┬──────────────────────────────────────┤
│ Operational Domain               │ Impact Upon Final FDA Revocation     │
├──────────────────────────────────┼──────────────────────────────────────┤
│ Medicare Part D Coverage         │ • Immediate loss of Part D status    │
│                                  │ • Cannot be paid under Part D benefit│
│                                  │ • Transition fill rules do not apply │
├──────────────────────────────────┼──────────────────────────────────────┤
│ Commercial Formulary & Claims    │ • System-wide claim rejection (NDC)  │
│                                  │ • Payer must issue member notices    │
├──────────────────────────────────┼──────────────────────────────────────┤
│ Manufacturer Copay Assistance    │ • Copay cards legally terminate      │
│                                  │ • OIG/Anti-Kickback rules prevent    │
│                                  │   copay subsidies on unapproved drugs│
├──────────────────────────────────┼──────────────────────────────────────┤
│ Specialty Pharmacy Dispensing    │ • Inventory quarantined / returned   │
│                                  │ • Distribution ceases immediately    │
├──────────────────────────────────┼──────────────────────────────────────┤
│ Clinical Continuity of Care      │ • Urgent steroid re-escalation or    │
│                                  │   switch to alternative regimens     │
└──────────────────────────────────┴──────────────────────────────────────┘

1. Medicare Part D and Transition Fill Failure

Under 42 CFR § 423.100, an unapproved drug cannot be covered under Medicare Part D. In normal formulary removals (such as tier changes or prior authorization additions), Medicare beneficiaries are entitled to a temporary 30-day supply under CMS transition fill policies, as detailed in our analysis of Part D transition fill versus manufacturer bridge.

However, transition fill protections do not apply to drugs that lose FDA approval. If Tavneos loses approval, Part D plans must terminate coverage immediately on the effective date of the FDA order, leaving no grace period for claims processing.

2. Collapse of Copay and Commercial Bridge Programs

Commercial manufacturer copay assistance programs rely on the drug being FDA-approved. Under federal healthcare fraud and abuse guidelines and commercial program terms, copay cards cannot subsidize unapproved compounds. Uninsured or underinsured patients relying on commercial copay cards would immediately face the full cash price or lose access entirely unless Amgen establishes an expanded access or compassionate-use protocol.

3. Specialty Pharmacy Inventory and Distribution

Because Tavneos is distributed through limited specialty pharmacy networks rather than retail pharmacies (explaining the 0 rows in the CMS NADAC dataset), specialty pharmacies would immediately quarantine inventory upon receipt of a final revocation notice.

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Decision Matrix: P&T Committee Action Options (Fall 2026)

When P&T committees evaluate Tavneos during current formulary cycles, they have three distinct pathways:

┌────────────────────────────────────────────────────────────────────────────────┐
│                   P&T Formulary Strategy Decision Pathways                     │
├───────────────────┬────────────────────────────┬───────────────────────────────┤
│ Option            │ Operational Mechanism      │ Clinical & Access Trade-offs  │
├───────────────────┼────────────────────────────┼───────────────────────────────┤
│ Pathway 1:        │ • Maintain existing PA;    │ • Preserves patient stability │
│ Active Monitoring │ • Add mandatory LFT logs;  │ • Zero mid-year disruption    │
│ (Recommended)     │ • Await Commissioner order │ • Requires active tracking    │
├───────────────────┼────────────────────────────┼───────────────────────────────┤
│ Pathway 2:        │ • Close to new starts;     │ • Prevents new risk exposure  │
│ Grandfathering /  │ • Grandfather existing     │ • Protects established cohort │
│ PA Restriction    │   patients on therapy      │ • Potential provider pushback │
├───────────────────┼────────────────────────────┼───────────────────────────────┤
│ Pathway 3:        │ • Issue 30/60-day notices; │ • High operational burden     │
│ Immediate Mid-Year│ • Execute formulary drop;  │ • Forces rapid steroid bridge │
│ Exclusion         │ • Manage appeals/exceptions│ • Risk of vasculitis flare    │
└───────────────────┴────────────────────────────┴───────────────────────────────┘

Strategic Recommendation for Access Leaders

For the vast majority of health plans, Pathway 2 (Grandfathering with Strict Hepatic Monitoring) represents the most defensible balance of patient safety, clinical continuity, and regulatory compliance:

• Block New Starts: Given the FDA's formal finding of lack of substantial evidence and the European withdrawal, initiating new patients on Tavneos when alternative induction regimens exist creates unnecessary clinical risk.
• Maintain Existing Patients with Enhanced Safety Checks: Abruptly discontinuing avacopan in patients who achieved clinical remission and successfully tapered glucocorticoids risks disease flare and severe steroid rebound. Plans should allow continuation for established patients, conditioned on verified normal liver enzymes and documented ongoing clinical stability.
• Prepare Transition Contingency Plans: Medical directors should collaborate with regional nephrology and rheumatology key opinion leaders to establish standardized tapering and transition protocols in the event that the FDA issues a final withdrawal order in 2027.

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Frequently Asked Questions (FAQ)

Can a health plan drop Tavneos from its formulary before the FDA finishes the hearing process?

Yes. Commercial health plans and self-funded employer plans have broad discretion under their contract terms to modify formularies mid-year, provided they comply with applicable state and federal notice requirements (typically 30 or 60 days advance notice to affected members and prescribers). For Medicare Part D, mid-year negative formulary changes for reasons other than immediate FDA market removal require CMS approval and advance notice under 42 CFR § 423.120(b)(5).

Is Tavneos still a covered Part D drug right now?

Yes. As of August 2026, Tavneos remains an FDA-approved prescription drug listed in the official Drugs@FDA and openFDA NDC directories under active status. It meets all statutory definitions of a covered Part D drug under Medicare Part D regulations.

Does the NEJM retraction change the FDA-approved labeling?

No. A medical journal retraction has no automatic legal effect on FDA-approved package inserts or prescribing information. FDA labeling can only be altered through an approved supplemental NDA (sNDA) submitted by the sponsor or through formal administrative action initiated by the agency. The FDA-approved label on DailyMed remains the official legal prescribing standard until modified by the agency.

Do the 76 liver-injury cases cited by FDA prove avacopan causes severe liver damage in all patients?

No. The FDA's 76-case series reflects a causality assessment of adverse event reports drawn from the sponsor's global safety database, the medical literature, and FAERS, in which avacopan was evaluated as possibly (72 cases) or probably (4 cases) causally associated. Seventy-four cases reported a serious outcome, including 54 hospitalizations and 8 deaths, and 7 reported biopsy-confirmed vanishing bile duct syndrome. A case series of this kind has no denominator of treated patients, so it establishes neither an incidence rate nor a per-patient risk. What it does establish is that the signal was serious enough for FDA to cite it in a withdrawal proceeding, which is why the label's liver monitoring schedule should be enforced rather than treated as optional.

Are vanishing bile duct syndrome (VBDS) cases occurring in US patients?

In our audit of openFDA FAERS data through Q1 2026, all 44 spontaneous reports containing the specific term "vanishing bile duct syndrome" carried a country of occurrence outside the United States (42 in Japan, 2 in Canada, 0 in the US). Two cautions apply. First, FDA's own case series — which draws on the sponsor's global safety database and the medical literature in addition to FAERS — identified 7 biopsy-confirmed VBDS cases without characterizing them as non-US, so the absence of US VBDS reports in a FAERS text query is not evidence that no US case exists. Second, 112 hepatic-term reports in this cohort do carry a US country of occurrence. The reporting cluster is real; the inference "this does not happen here" is not supported.

What happens to the manufacturer copay assistance program if FDA withdraws approval?

If the FDA issues a final order revoking approval of NDA 214487, commercial copay assistance cards will cease to function immediately. Under federal anti-kickback statutes and pharmaceutical compliance standards, manufacturer copay programs cannot support unapproved or withdrawn medications.

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Sources

1. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Proposal to Withdraw Marketing Approval; Notice of Opportunity for a Hearing (NOOH), NDA 214487 (TAVNEOS). Issued April 27, 2026. FDA Media Archive.
2. Federal Register / Food and Drug Administration. ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing. 91 FR 23278, Document No. 2026-08455, Docket No. FDA-2026-N-1321. Published April 30, 2026. Federal Register.
3. U.S. Food and Drug Administration. CDER Proposes to Withdraw Approval of TAVNEOS. Drug Alerts and Statements. Content current as of July 13, 2026. FDA.gov.
4. Regulations.gov. Public Docket: ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan). Docket ID: FDA-2026-N-1321. Accessed August 17, 2026. Regulations.gov.
5. European Medicines Agency (EMA). Tavneos - Referral under Article 20 of Regulation (EC) No 726/2004. Human Medicines Referrals. Decision adopted August 4, 2026. EMA Referral Portal.
6. European Medicines Agency (EMA). EMA Recommends Revoking Marketing Authorisation for Tavneos. Press Release. Published June 26, 2026. EMA Newsroom.
7. CSL Vifor / Vifor Fresenius Medical Care Renal Pharma. European Commission Adopts Decision to Revoke Marketing Authorisation for TAVNEOS (avacopan) in the European Union and EEA Countries. Company Announcement. Issued August 6, 2026. CSL Newsroom.
8. Amgen Inc. Amgen Statement on FDA Data Submission for TAVNEOS (avacopan). Prescriber Information Update. Last updated July 24, 2026. Amgen HCP Portal.
9. New England Journal of Medicine. Retraction: Jayne DRW et al. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med 2021;384:599-609. Retraction Notice, DOI 10.1056/NEJMe2608684. Published June 29, 2026. NEJM.
10. UnitedHealthcare Pharmacy Clinical Programs. Tavneos (avacopan) Prior Authorization / Notification Program Number 2026 P 1377-5. Effective April 1, 2026. UHC Provider.
11. U.S. Food and Drug Administration. Drugs@FDA Relational Export: Applications, Products, Submissions, and MarketingStatus Tables. Data snapshot July 30, 2026. Drugs@FDA Databases.
12. openFDA / U.S. Food and Drug Administration. National Drug Code (NDC) Directory JSON API & Export. Data snapshot July 25, 2026. openFDA NDC.
13. openFDA / U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Full Partitioned Dataset (2021–2026). Export snapshot June 10, 2026. openFDA FAERS.
14. Centers for Medicare & Medicaid Services (CMS). National Average Drug Acquisition Cost (NADAC) Weekly Pricing Files. Data snapshot July 24, 2026. Medicaid.gov.