Tavneos - referral

Current status

Procedure started

Overview

EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA.

Review prompted by questions regarding data integrity of main study

Background

EMA’s human medicines committee (CHMP) has started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the Advocate study, which was the main study supporting the medicine’s marketing authorisation in the European Union.

Tavneos was authorised in the EU in January 2022 for treating adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory conditions of the blood vessels.

In the Advocate study, which included 331 patients with GPA or MPA, Tavneos was compared with high-dose corticosteroids (medicines used to treat inflammatory diseases), both in addition to standard treatment (either rituximab or a regimen consisting of cyclophosphamide followed by azathioprine). Based on data from this study, Tavneos was found to be at least as effective as high-dose corticosteroids in inducing remission in patients with GPA or MPA and to lead to better long-term remission rates.

The concerns relate to how the data for the Advocate study was handled before Tavneos was authorised, which may have impacted the findings on the medicine’s effectiveness.

EMA will now review all available data to assess whether this emerging information has an impact on the balance of benefits and risks of Tavneos. The Agency will then issue a recommendation on whether the marketing authorisation in the EU should be maintained, amended, suspended or revoked.

More about the medicine

Tavneos is a medicine used to treat adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels. Tavneos is used as part of a combined treatment also including the medicines rituximab or cyclophosphamide. Tavneos contains the active substance avacopan.

More information on Tavneos is available on the medicine’s page.

More about the procedure

The review of Tavneos has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.

The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Tavneos Article-20 procedure: EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA

Reference Number: EMA/18986/2026

Key facts

About this medicine

• Approved name:
  Tavneos
• International non-proprietary name (INN) or common name:
  avacopan
• Class:
  Antineoplastic and immunomodulating agents

About this procedure

• Current status:
  Procedure started
• Reference number:
  EMA/REF/0000325221
• Type:
  Article 20 procedures

  This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

• Authorisation model:
  Centrally authorised product(s)
• Decision making model:
  CHMP-EC

Key dates and outcomes

• Procedure start date:
  29/01/2026

All documents

Procedure started

Tavneos Article-20 procedure: Notification

Tavneos Article-20 procedure: CHMP list of questions

Reference Number: EMADOC-1700519818-2855720

Tavneos Article-20 procedure: Timetable for the procedure

Reference Number: EMADOC-1700519818-2855721

Tavneos Article-20 procedure: EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA

Reference Number: EMA/18986/2026

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.