Announced details
Treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA)
In many cases, hepatic dysfunction develops within 3 months of treatment initiation.
The Company has been sublicensed the rights to Tavneos in Japan by Vifor Fresenius Medical Care Renal Pharma Ltd. The Company revised the package insert at the direction of the Ministry of Health, Labour and Welfare.
The Ministry of Health, Labour and Welfare is a Japanese government agency. ChemoCentryx, Inc. is a U.S. company that developed Tavneos and was acquired by Amgen in 2022. Vifor Fresenius Medical Care Renal Pharma Ltd. was granted rights in certain countries outside the United States by ChemoCentryx, Inc. and subsequently sublicensed the rights to Tavneos in Japan to the Company.
19-48 Yoshino, Matsumoto, Nagano Prefecture (the Company's head office)
Currently under review. If it becomes clear that the matter will affect financial results, the Company will make a timely disclosure.
The company does not address Contract Value / Offering price.
Direction from the Ministry of Health, Labour and Welfare; revised package insert; safety alert (Blue Letter)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Tavneos (generic name: avacopan) |
| Counterparty | Ministry of Health, Labour and Welfare; ChemoCentryx, Inc.; Vifor Fresenius Medical Care Renal Pharma Ltd. |
| Counterparty overview | The Ministry of Health, Labour and Welfare is a Japanese government agency. ChemoCentryx, Inc. is a U.S. company that developed Tavneos and was acquired by Amgen in 2022. Vifor Fresenius Medical Care Renal Pharma Ltd. was granted rights in certain countries outside the United States by ChemoCentryx, Inc. and subsequently sublicensed the rights to Tavneos in Japan to the Company. |
| Relationship with the Company | The Company has been sublicensed the rights to Tavneos in Japan by Vifor Fresenius Medical Care Renal Pharma Ltd. The Company revised the package insert at the direction of the Ministry of Health, Labour and Welfare. |
| Applicable area | Treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) |
| Location | 19-48 Yoshino, Matsumoto, Nagano Prefecture (the Company's head office) |
| Quantitative Effects | In many cases, hepatic dysfunction develops within 3 months of treatment initiation. |
| Impact on Business Performance | Currently under review. If it becomes clear that the matter will affect financial results, the Company will make a timely disclosure. |
| Source | Direction from the Ministry of Health, Labour and Welfare; revised package insert; safety alert (Blue Letter) |
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.Serious hepatic dysfunction may occur, and cases resulting in death have been reported. The measures are being taken at the direction of the Ministry of Health, Labour and Welfare.