European authorities' position on TAVNEOS
TAVNEOS (generic name: avacopan) in the European Union (EU)
Concerns arose regarding the integrity of data from the multinational Phase III clinical trial. The CHMP stated that it had not been demonstrated that the benefits of this product outweigh its risks.
Related procedures
Review by the Committee for Medicinal Products for Human Use (CHMP) and recommendation to revoke the marketing authorization in the EU
European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Commission (EC)
The Company is currently assessing the impact of this matter on its financial results. If it becomes clear that the matter will affect its financial results, the Company will make a timely disclosure.
Company response
Review by the Committee for Medicinal Products for Human Use (CHMP) (commenced on 30 January 2026)
The CHMP's opinion has been submitted to the European Commission (EC), which is expected to make the final decision in due course. The Company has reported the matter to the Ministry of Health, Labour and Welfare and PMDA and is consulting with them regarding its response in Japan. If it becomes clear that the matter will affect its financial results, the Company will make a timely disclosure.
If it becomes clear that the matter will affect the Company's financial results, the Company will make a timely disclosure.
| Item | Details |
|---|---|
| Event name | European authorities' position on TAVNEOS |
| Date of occurrence | 26 June 2026 (local time; date of the CHMP's opinion) |
| Target Locations / Products | TAVNEOS (generic name: avacopan) in the European Union (EU) |
| Cause | Concerns arose regarding the integrity of data from the multinational Phase III clinical trial. The CHMP stated that it had not been demonstrated that the benefits of this product outweigh its risks. |
| Impact on Earnings Forecast | The Company is currently assessing the impact of this matter on its financial results. If it becomes clear that the matter will affect its financial results, the Company will make a timely disclosure. |
| Type of litigation or proceeding | Review by the Committee for Medicinal Products for Human Use (CHMP) and recommendation to revoke the marketing authorization in the EU |
| Court or authority | European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Commission (EC) |
| Date of filing / date of action | 26 June 2026 (date of the CHMP's opinion) |
| Investigation structure | Review by the Committee for Medicinal Products for Human Use (CHMP) (commenced on 30 January 2026) |
| Outlook | The CHMP's opinion has been submitted to the European Commission (EC), which is expected to make the final decision in due course. The Company has reported the matter to the Ministry of Health, Labour and Welfare and PMDA and is consulting with them regarding its response in Japan. If it becomes clear that the matter will affect its financial results, the Company will make a timely disclosure. |
| Planned follow-up disclosure | If it becomes clear that the matter will affect the Company's financial results, the Company will make a timely disclosure. |
Items this document does not state (14)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Concerns arose regarding the integrity of data from the multinational Phase III clinical trial, and the CHMP determined that it had not been demonstrated that the benefits of this product outweigh its risks.