Notice Regarding Report and Deliberation Results at the Pharmaceutical Affairs and Food Sanitation Council, Second Committee on Pharmaceuticals, Concerning Tabneos

Key Points

This matter concerns the deliberation results at the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs and Food Sanitation Council for Tabneos (generic name: abacopan) and the announced future usage policy. The council judged that there are doubts about the reliability of the submitted materials and concluded that it cannot be determined that the benefits outweigh the risks. As measures, it requested refraining from initiating new treatments, and for patients currently receiving treatment to consider discontinuation or switching to alternative therapies, while urging continued proper use. The Company is examining the impact on its business performance and will make a separate disclosure if any impact becomes apparent.

Future Response and Impact

The Ministry has already notified medical institutions of this policy and provided the drug consultation center as a contact point for healthcare professionals and patients. In the short term, cautious clinical use is expected to continue, requiring consideration of each patient's condition and alternative treatments. The impact on business performance is undetermined, and the Company plans to make additional disclosures depending on future developments.