Announced details
Treatment of chronic limb-threatening ischemia (CLTI) in patients with peripheral artery disease (PAD)
Approximately 200 million people worldwide have PAD; the five-year mortality rate after major lower-limb amputation is 57% (compared with 80% for lung cancer).
The FDA is the agency with which the Company discusses its BLA application strategy and submission materials for products it is developing in the United States.
U.S. government agency responsible for regulating pharmaceuticals, biologics and other products
There will be no impact on consolidated financial results from not holding the Pre-BLA Meeting.
The company does not address Contract Value / Offering price.
FDA；Allison MA et al., Circulation (2023)；Armstrong DG et al., N Engl J Med (2017)；Armstrong DG et al., Journal of Foot and Ankle Research (2020)；Global Vascular Guidelines (Journal of Vascular Surgery, 2019)
| Item | Details |
|---|---|
| Names of Products / Services Covered | HGF gene therapy product (generic name: beperminogene perplasmid) |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | U.S. government agency responsible for regulating pharmaceuticals, biologics and other products |
| Relationship with the Company | The FDA is the agency with which the Company discusses its BLA application strategy and submission materials for products it is developing in the United States. |
| Applicable area | Treatment of chronic limb-threatening ischemia (CLTI) in patients with peripheral artery disease (PAD) |
| Quantitative Effects | Approximately 200 million people worldwide have PAD; the five-year mortality rate after major lower-limb amputation is 57% (compared with 80% for lung cancer). |
| Impact on Business Performance | There will be no impact on consolidated financial results from not holding the Pre-BLA Meeting. |
| Source | FDA；Allison MA et al., Circulation (2023)；Armstrong DG et al., N Engl J Med (2017)；Armstrong DG et al., Journal of Foot and Ankle Research (2020)；Global Vascular Guidelines (Journal of Vascular Surgery, 2019) |
Items this document does not state (10)
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.Before the Pre-BLA Meeting, the Company submitted questions to the FDA in writing and received sufficient answers, along with confirmation that there were no issues with the planned rolling submission or the submission materials.