Announced details
Treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), and treatment of rare diseases in the renal field and other areas
The company manufactures and markets Tavneos in Japan and submitted a response after receiving a reporting order from the Minister of Health, Labour and Welfare. The Ministry of Health, Labour and Welfare decided to request that medical institutions and others take the relevant measures.
Reviewed by the Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs Council of the Ministry of Health, Labour and Welfare. The Pharmaceuticals and Medical Devices Agency reviewed the response letter. Other details are Not disclosed.
The impact is currently under review. If it becomes clear that the matter will affect future results, the company will make a timely disclosure.
The company does not address Contract Value / Offering price.
Ministry of Health, Labour and Welfare; Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs Council; Pharmaceuticals and Medical Devices Agency
| Item | Details |
|---|---|
| Names of Products / Services Covered | Tavneos (generic name: avacopan) |
| Counterparty | Ministry of Health, Labour and Welfare; Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs Council; Pharmaceuticals and Medical Devices Agency |
| Counterparty overview | Reviewed by the Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs Council of the Ministry of Health, Labour and Welfare. The Pharmaceuticals and Medical Devices Agency reviewed the response letter. Other details are Not disclosed. |
| Relationship with the Company | The company manufactures and markets Tavneos in Japan and submitted a response after receiving a reporting order from the Minister of Health, Labour and Welfare. The Ministry of Health, Labour and Welfare decided to request that medical institutions and others take the relevant measures. |
| Applicable area | Treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), and treatment of rare diseases in the renal field and other areas |
| Impact on Business Performance | The impact is currently under review. If it becomes clear that the matter will affect future results, the company will make a timely disclosure. |
| Source | Ministry of Health, Labour and Welfare; Second Subcommittee on Pharmaceuticals of the Pharmaceutical Affairs Council; Pharmaceuticals and Medical Devices Agency |
Items this document does not state (11)
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.Because potential issues with the reliability of the materials submitted during the approval review were confirmed, making it difficult to conclude that the therapeutic benefits of this drug outweigh its risks. It was also determined that, because the target diseases are serious rare diseases, treatment changes for patients currently receiving the drug must be decided on an individual basis.