The Avacopan Vifor Suspension as a Decision Governance Case
Avacopan Vifor was suspended for new UK patients after regulators concluded that the pivotal study supporting its authorisation could no longer reliably demonstrate efficacy. The case shows how new information can reopen an earlier decision and initiate a new cycle of Reaction, Explanation, Search, Decision, and Action.
- Avacopan Vifor was authorised in the UK in 2022, but information that emerged later raised questions about the integrity and reliability of the pivotal clinical study supporting that authorisation. - The MHRA reopened the benefit-risk assessment in June 2026, considering available evidence, independent expert advice, and representations from patients and healthcare professionals. - On 1 September 2026, the MHRA suspended use, supply, and sale of the medicine to new patients and established a six-month managed withdrawal period for existing patients. - The case illustrates how new information can cause an earlier decision to be reopened, creating a new sequence of Reaction, Explanation, Search, Decision, and Action.
Avacopan Vifor, previously known as Tavneos, is used to treat adults with severe forms of granulomatosis with polyangiitis and microscopic polyangiitis, two rare autoimmune diseases affecting small blood vessels. The medicine was authorised in the UK on 6 May 2022. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
Four years later, the Medicines and Healthcare products Regulatory Agency, or MHRA, reconsidered that authorisation after receiving information that raised questions about the integrity and reliability of the pivotal clinical study used to establish the medicine’s efficacy.
On 1 September 2026, the MHRA announced that the medicine would no longer be supplied to new patients. Existing patients could continue receiving it during a six-month managed withdrawal period while clinicians considered alternative treatments. The regulator stated that it intended to revoke the UK marketing authorisation on 1 March 2027. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
The case can be interpreted as a decision process in which a previous decision is reopened when the information supporting it changes.
# The Five-Stage Decision Process
The five-stage decision model describes decision making as a progression from **Reaction** to **Explanation**, **Search**, **Decision**, and **Action**. Reaction begins when an event, observation, or change creates a perceived need to act. Explanation develops an account of the situation, its causes, and why intervention may be necessary. Search identifies possible courses of action, relevant evidence, expected outcomes, assumptions, and criteria for comparing alternatives. Decision is the commitment to one option, including any conditions attached to that choice. Action translates the commitment into implementation and produces outcomes that can subsequently provide information for evaluating the decision and improving future decisions.
Decision governance influences each stage by determining who participates, who has authority, what information is required, how alternatives are considered, and how the reasoning and resulting commitments are recorded.
# Avacopan Is Authorised
Avacopan was authorised in the UK on 6 May 2022 for use, together with rituximab or cyclophosphamide regimens, in adults with severe active granulomatosis with polyangiitis or microscopic polyangiitis. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
A central source of evidence for the authorisation was the Advocate clinical study.
The corresponding study used for the European authorisation included 331 patients. Avacopan was compared with a corticosteroid-based treatment, with both groups also receiving standard treatment. Based on the data available at the time, the study indicated that avacopan was at least as effective as the comparator in inducing remission and produced better long-term remission rates at 52 weeks. ([ema.europa.eu](https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa))
The regulatory authorisation represented a **Decision** followed by **Action**.
The evidence available at the time supported a regulatory commitment that allowed the medicine to enter clinical use. Healthcare professionals could prescribe it, patients could receive it, and subsequent experience with the medicine could produce additional information.
The Action stage therefore also created the conditions for later decision processes.
# Questions Emerge About the Evidence
In 2026, information emerged that raised questions about how data from the Advocate study had been handled.
The European Medicines Agency stated that the concerns related to the handling of the study data before authorisation and that this could have affected findings concerning the effectiveness of the medicine. ([ema.europa.eu](https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa))
This event can be interpreted as a new **Reaction**.
The relevant change was not a new decision about the medicine. It was new information about information used in an earlier decision.
This distinction is relevant to decision governance. Decisions under uncertainty necessarily rely on information that may later be revised, supplemented, or challenged. Governance can therefore include mechanisms for reopening decisions when the credibility or relevance of their supporting information changes.
The 2022 authorisation did not end the decision process permanently. New information created a reason to reconsider the earlier commitment.
# European Regulators Open a Review
The European review began on 29 January 2026 at the request of the European Commission.
The Committee for Medicinal Products for Human Use, or CHMP, was asked to review the available evidence and determine whether the marketing authorisation should be maintained, amended, suspended, or revoked. ([ema.europa.eu](https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa))
The alternatives were therefore specified before the review concluded.
This represents the beginning of another **Search** stage.
The question was no longer whether the original authorisation had been justified using the information available in 2022. The decision problem had changed.
The new question was whether the remaining evidence still supported the benefit-risk relationship required for continued authorisation.
This illustrates how the same object of decision, in this case the marketing authorisation for a medicine, can appear in several different decision situations over time.
The information, uncertainty, alternatives, and expected consequences associated with the decision had changed.
# The MHRA Opens Its Own Review
On 5 June 2026, the MHRA announced that it was reviewing the benefits and risks of avacopan in the UK.
The regulator stated that the review had been prompted by information raising questions about the integrity and reliability of data from the pivotal clinical study underpinning the UK licence.
The review was intended to determine whether the new information changed what the study demonstrated about effectiveness and, consequently, whether it changed the overall benefit-risk assessment. ([gov.uk](https://www.gov.uk/government/news/mhra-review-of-the-benefits-and-risks-of-avacopan))
The MHRA also identified the decision authority governing the review.
Under the Human Medicines Regulations 2012, the regulator may vary, suspend, or revoke an authorisation where the material supplied in support of it is incorrect or no longer supports a positive benefit-risk balance. ([gov.uk](https://www.gov.uk/government/news/mhra-review-of-the-benefits-and-risks-of-avacopan))
This is a decision-governance mechanism.
The rule specifies both a condition under which an earlier decision can be reconsidered and the authority that can reconsider it.
The earlier authorisation is therefore not an unconditional commitment. It remains subject to evidence requirements that continue after the initial decision.
# Regulators Reassess the Explanation
As the reviews progressed, the interpretation of the available evidence changed.
On 25 June 2026, the European CHMP concluded that the Advocate study had been conducted in breach of good clinical practice principles and that data supplied during the original authorisation process were incorrect and misleading.
The committee concluded that those data could no longer be relied upon to demonstrate the effectiveness of Tavneos. It also considered supportive post-marketing information and post-hoc analyses insufficient to establish the benefits of the medicine. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/referrals/tavneos))
This changes the **Explanation** associated with the regulatory decision.
The new explanation was not that new controlled evidence had established that the medicine had no therapeutic effect.
Instead, the evidential basis for concluding that the medicine was effective had changed.
This distinction changes the structure of the decision problem.
If the pivotal evidence cannot be relied upon, then the regulator must reassess the relationship between demonstrated benefits and known risks using the information that remains.
The Explanation stage therefore concerns not only explanations of observed outcomes but also explanations of why particular information should or should not be relied upon when making the decision.
# Other Information Is Integrated
The regulatory process involved information from several sources.
The CHMP considered the available clinical evidence, post-marketing data, analyses of the Advocate study, views from patient and healthcare professional representatives, and written interventions from third parties. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/referrals/tavneos))
The European process also incorporated an assessment from the Pharmacovigilance Risk Assessment Committee concerning liver safety. That committee had recommended stronger liver-function monitoring following reports of serious liver injury, including fatal cases. ([ema.europa.eu](https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-june-2026))
The UK process similarly incorporated several sources of information.
The MHRA stated that it conducted a detailed assessment of all available evidence, received advice from the independent Commission on Human Medicines, and considered representations from patients and healthcare professionals. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
In decision governance terms, this is **information integration during Search**.
Different participants contribute different types of information.
Regulatory specialists assess the clinical and statutory evidence. Independent experts provide scientific advice. Patients and healthcare professionals provide information from perspectives affected by the resulting decision.
The process therefore does not rely on one source of decision information.
# The European Decision Is Made
The CHMP recommended on 25 June that the European marketing authorisation should be revoked.
The European Commission issued the legally binding decision on 4 August 2026. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/referrals/tavneos))
No new patients were to start treatment with Tavneos, while patients already receiving it were to move to alternative treatments. Additional monitoring requirements were specified because of the known risks of liver injury. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/referrals/tavneos))
This represents another **Decision**.
The earlier commitment to allow the medicine to be marketed was replaced by a new commitment based on a revised assessment of the information available.
The case therefore contains decisions nested across time.
An authorisation decision is followed by a review decision, which produces another regulatory decision and subsequent implementation decisions.
# The MHRA Makes the UK Decision
On 1 September 2026, the MHRA completed its review.
It concluded that the available evidence no longer supported a positive benefit-risk balance and that the pivotal study could no longer be relied upon to demonstrate the efficacy of Avacopan Vifor. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
The regulator suspended the use, supply, and sale of Avacopan Vifor to new patients from that date.
It made a different arrangement for patients already receiving the medicine.
Supply to existing patients would be permitted during a six-month managed withdrawal period. Healthcare professionals were instructed to review those patients and consider suitable alternative treatments. The marketing authorisation holder guaranteed supply during the transition period. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
The MHRA stated that it intended to revoke the UK marketing authorisation on 1 March 2027.
The **Decision** therefore contained more than a binary choice between continued authorisation and immediate withdrawal.
Different commitments applied to different groups.
New patients could no longer begin treatment.
Existing patients could continue temporarily.
Healthcare professionals were assigned responsibility for reviewing treatment.
The manufacturer was expected to maintain supply during the transition.
The regulator specified a later point at which it intended to revoke the authorisation.
# The Decision Moves Into Action
The announcement on 1 September also initiated the **Action** stage.
Healthcare professionals were instructed not to initiate new patients on Avacopan Vifor and to review existing patients as soon as possible.
Patients were advised not to stop taking the medicine without consultation with their specialist.
Existing requirements concerning liver-function testing, white blood cell monitoring, and serious infections remained in place during the transition. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))
Implementation is consequently distributed across several agents.
The regulator changes the regulatory status of the medicine.
The marketing authorisation holder maintains supply during the withdrawal period.
Healthcare professionals review individual treatment decisions.
Patients participate in decisions about transitioning to alternative therapies.
The Action stage of the regulatory decision therefore creates additional decisions at other levels.
# Interpreting the Case Through Decision Governance
The case can be represented as a sequence:
**Reaction:** Information emerges that raises questions about the integrity and reliability of evidence supporting an existing medicine authorisation.
**Explanation:** Regulators investigate whether problems with the pivotal study change what can be concluded about the efficacy of the medicine and its benefit-risk balance.
**Search:** Available evidence is reassessed, independent expert advice is obtained, patient and healthcare professional representations are considered, and regulatory alternatives include maintaining, varying, suspending, or revoking the authorisation.
**Decision:** European regulators revoke the EU authorisation, while the MHRA suspends use for new UK patients and establishes a managed withdrawal for existing patients, with intended revocation in March 2027.
**Action:** Clinicians review existing patients, alternative treatments are considered, supply is maintained temporarily, and monitoring requirements continue during withdrawal.
Several decision-governance mechanisms are visible across these stages.
Authority is specified in regulation.
Conditions for reopening a previous decision are defined.
Independent expertise is incorporated.
Information from several sources is considered.
Alternative regulatory actions are available.
Different responsibilities are assigned to regulators, the marketing authorisation holder, healthcare professionals, and patients.
The case also illustrates that the five stages need not form a process that happens only once.
The original authorisation moved from Decision into Action in 2022.
Information generated or discovered later created another Reaction.
That Reaction initiated another Explanation and Search, followed by another Decision and Action.
Decision processes can therefore form loops.
Action produces new information. New information can change assumptions, challenge explanations, or alter expected outcomes. When that information is sufficiently relevant, decision governance can specify that an existing commitment should be reconsidered.
In the Avacopan case, what changed was not only information about the consequences of a decision. Information about the reliability of the evidence used to make the earlier decision changed.
The case therefore illustrates a broader role of decision governance: not only organizing how commitments are made, but also establishing how previous commitments are revisited when the information on which they depend changes.
# References
European Medicines Agency. *EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA*. 30 January 2026. ([ema.europa.eu](https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa))
European Medicines Agency. *Tavneos: referral*. Article 20 procedure, 2026. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/referrals/tavneos))
European Medicines Agency. *Meeting highlights from the Pharmacovigilance Risk Assessment Committee, 8–11 June 2026*. ([ema.europa.eu](https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-june-2026))
Medicines and Healthcare products Regulatory Agency. *MHRA review of the benefits and risks of avacopan*. 5 June 2026. ([gov.uk](https://www.gov.uk/government/news/mhra-review-of-the-benefits-and-risks-of-avacopan))
Medicines and Healthcare products Regulatory Agency. *MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance*. 1 September 2026. ([gov.uk](https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance))