Announced details
Treatment of microscopic polyangiitis and granulomatosis with polyangiitis, and treatment of rare diseases in nephrology and other fields
In June 2017, the Company acquired the exclusive rights to develop and commercialize the product in Japan from Vifor Fresenius Medical Care Renal Pharma Ltd. and has sold it in Japan since June 2022. ChemoCentryx licensed worldwide rights outside the US to Vifor, which sublicensed the Japanese rights to the Company.
Vifor Fresenius Medical Care Renal Pharma Ltd. licensed the exclusive rights to develop and commercialize this product in Japan to the Company. It is now CSL Vifor. ChemoCentryx originated the product and has since been acquired by Amgen. The FDA is the US regulatory authority, the EMA is Europe's medicines regulator, the PMDA is Japan's Pharmaceuticals and Medical Devices Agency, and the Ministry of Health, Labour and Welfare is a Japanese government ministry.
The impact of this matter on the Company's performance is currently under review. Sales of the product for the fiscal year ending March 2026 were ¥11.524 billion.
The company does not address Contract Value / Offering price.
US Food and Drug Administration (FDA), FDA Center for Drug Evaluation and Research (CDER), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Tavneos (generic name: avacopan) |
| Counterparty | Vifor Fresenius Medical Care Renal Pharma Ltd. (now CSL Vifor), U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Health, Labour and Welfare |
| Counterparty overview | Vifor Fresenius Medical Care Renal Pharma Ltd. licensed the exclusive rights to develop and commercialize this product in Japan to the Company. It is now CSL Vifor. ChemoCentryx originated the product and has since been acquired by Amgen. The FDA is the US regulatory authority, the EMA is Europe's medicines regulator, the PMDA is Japan's Pharmaceuticals and Medical Devices Agency, and the Ministry of Health, Labour and Welfare is a Japanese government ministry. |
| Relationship with the Company | In June 2017, the Company acquired the exclusive rights to develop and commercialize the product in Japan from Vifor Fresenius Medical Care Renal Pharma Ltd. and has sold it in Japan since June 2022. ChemoCentryx licensed worldwide rights outside the US to Vifor, which sublicensed the Japanese rights to the Company. |
| Contract Date | June 2017 (news release dated 9 June 2017) |
| Launch date | June 2022 (sales launched in Japan; sales performance) |
| Applicable area | Treatment of microscopic polyangiitis and granulomatosis with polyangiitis, and treatment of rare diseases in nephrology and other fields |
| Impact on Business Performance | The impact of this matter on the Company's performance is currently under review. Sales of the product for the fiscal year ending March 2026 were ¥11.524 billion. |
| Source | US Food and Drug Administration (FDA), FDA Center for Drug Evaluation and Research (CDER), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) |
Items this document does not state (9)
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.The company began providing information with patient safety as its top priority following the FDA's identification of severe drug-induced liver injury, the proposed withdrawal of US approval, issues concerning material facts in the efficacy data and marketing authorization application documents, and the EMA's review of the integrity of clinical trial data.