Kissei Pharmaceutical Co., Ltd.
Notice Regarding the European Authority’s View on Tabneos
The European authorities pointed out concerns about the consistency of Tabneos (Abacopan) international joint Phase III clinical trial data, and CHMP recommended the withdrawal of marketing authorization in the EU. The Japanese side is discussing responses with the Ministry of Health, Labour and Welfare and PMDA. The impact on financial results is uncertain; disclosure will be made once the impact becomes clear.
Key Figures
- Unknown: Sales revenue
- Unknown: Operating income
- Unknown: Net income for the period
AI要約
Background and factual relationship
This notice is based on the European Authority's view regarding concerns over the consistency of international joint Phase III clinical trial data for Tabneos (Avacopan), and the public release of the CHMP evaluation results. EMA began review on January 30, 2026, and CHMP advised the withdrawal of the marketing authorization in the EU, citing that the benefits of the drug cannot be demonstrated to outweigh the risks. A final decision has been submitted to the European Commission and is expected to be made in the future.
Japanese response and impact
Our company has reported the CHMP's view to the Ministry of Health, Labour and Welfare and PMDA, and is discussing responses in Japan. The impact on our financial results is under careful analysis, and once clarified, will be promptly disclosed. Additionally, a news release includes supplementary context regarding the technology transfer agreement dated June 9, 2017.
Kissei Pharmaceutical Company, Limited
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