KISSEI PHARMACEUTICAL CO.,LTD. [4547.T]
TOKYO, Jun 29 (Pulse News Wire) – Kissei Pharmaceutical CO.,LTD. (4547.T) reported on Thursday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended revoking the marketing authorization for Tavneos (generic name: Avacopan) due to concerns over the consistency of international Phase III clinical trial data.
The recommendation was made public on January 30, 2026. Tavneos is developed by Chemocentryx and licensed to Vifor Fresenius Medical Care Renal Pharma (VFMRP) outside the United States for distribution by VFMRP's parent company CSL Limited and affiliates. Kissei holds a sublicense for the drug’s commercialization in Japan. Chemocentryx was acquired by Amgen in 2022.
In detail, CHMP concluded on June 26, 2026 that the benefits of Tavneos did not outweigh the risks, leading to the recommendation for withdrawal in the European Union. The final decision rests with the European Commission (EC). Kissei has informed the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency (PMDA) about the situation and is discussing appropriate actions. The potential impact on Kissei's performance will be assessed further, and any significant effects will be disclosed promptly.
🟢 Confidence: High AI-translated content.