Announced details
Treatment of erythrocytosis in adults with polycythemia vera (PV)
76.9% of patients achieved a clinical response between Weeks 20 and 32 of treatment. Control of hematocrit levels, a reduction in the number of phlebotomies, and improvements in fatigue.
Takeda Pharmaceutical Company Limited submitted a new drug application to the U.S. FDA and obtained approval. MIMRYLO was discovered and developed by Protagonist Therapeutics, and Takeda Pharmaceutical Company Limited holds exclusive worldwide development and commercialization rights.
U.S. pharmaceutical regulatory authority
U.S. Food and Drug Administration (FDA)
No change to the consolidated earnings forecast for the fiscal year ending March 2027 (fiscal 2026).
The company does not address Contract Value / Offering price.
Phase 3 VERIFY trial (NCT05210790), References 1–5
| Item | Details |
|---|---|
| Names of Products / Services Covered | MIMRYLO™（rusfertide） |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | U.S. pharmaceutical regulatory authority |
| Relationship with the Company | Takeda Pharmaceutical Company Limited submitted a new drug application to the U.S. FDA and obtained approval. MIMRYLO was discovered and developed by Protagonist Therapeutics, and Takeda Pharmaceutical Company Limited holds exclusive worldwide development and commercialization rights. |
| Applicable area | Treatment of erythrocytosis in adults with polycythemia vera (PV) |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
| Quantitative Effects | 76.9% of patients achieved a clinical response between Weeks 20 and 32 of treatment. Control of hematocrit levels, a reduction in the number of phlebotomies, and improvements in fatigue. |
| Impact on Business Performance | No change to the consolidated earnings forecast for the fiscal year ending March 2027 (fiscal 2026). |
| Source | Phase 3 VERIFY trial (NCT05210790), References 1–5 |
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 drug met the efficacy endpoints and demonstrated a favorable safety profile in the Phase 3 VERIFY trial. The trial confirmed control of hematocrit levels, a reduction in the number of phlebotomies, and improvements in fatigue.