Announced details
Primary IgA nephropathy in adults, reduction of proteinuria, slowing progression to kidney failure, and improvement of kidney function
eGFR was statistically significantly stabilized over 24 months, demonstrating an improvement in kidney function. This is consistent with the KDIGO treatment target of limiting the annual decline in kidney function to less than 1 mL/min/1.73 m² per year.
Otsuka Pharmaceutical and OPDC have submitted a supplemental Biologics License Application (sBLA) to the FDA seeking full approval for VOYXACT.
The US regulatory authority for pharmaceuticals. Location and other details: Not disclosed.
Trial number: NCT05248646. Other details: Not disclosed
Otsuka Pharmaceutical: Tokyo. OPDC: Princeton, New Jersey, U.S.
There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. VOYXACT is positioned as one of the products expected to drive future growth, and this development is recognized as important progress toward enhancing corporate value over the medium to long term.
The company does not address Contract Value / Offering price.
International guidelines for the treatment of kidney disease (KDIGO)
| Item | Details |
|---|---|
| Names of Products / Services Covered | VOYXACT® (sibeprenlimab) |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | The US regulatory authority for pharmaceuticals. Location and other details: Not disclosed. |
| Relationship with the Company | Otsuka Pharmaceutical and OPDC have submitted a supplemental Biologics License Application (sBLA) to the FDA seeking full approval for VOYXACT. |
| Launch date | November 2025 (when the US FDA granted accelerated approval; the date full approval began is Not disclosed) |
| Applicable area | Primary IgA nephropathy in adults, reduction of proteinuria, slowing progression to kidney failure, and improvement of kidney function |
| Registration number and expiry date | Trial number: NCT05248646. Other details: Not disclosed |
| Location | Otsuka Pharmaceutical: Tokyo. OPDC: Princeton, New Jersey, U.S. |
| Quantitative Effects | eGFR was statistically significantly stabilized over 24 months, demonstrating an improvement in kidney function. This is consistent with the KDIGO treatment target of limiting the annual decline in kidney function to less than 1 mL/min/1.73 m² per year. |
| Impact on Business Performance | There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. VOYXACT is positioned as one of the products expected to drive future growth, and this development is recognized as important progress toward enhancing corporate value over the medium to long term. |
| Source | International guidelines for the treatment of kidney disease (KDIGO) |
Items this document does not state (7)
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.Data from the full VISIONARY trial period became available, showing stabilization and improvement in kidney function compared with the placebo group, based on both the annual rate of change in eGFR and the mean change from baseline.