Announced details
Improvement of chronic motor paralysis associated with traumatic brain injury
Change from baseline in FMMS was 8.3±10.6 in 46 patients in the SB623 group and 2.3±4.7 in 15 patients in the sham-surgery group (24 weeks, p=0.0401)
Product designated under the Sakigake designation system, RMAT designation, ATMP designation
Ministry of Health, Labour and Welfare; U.S. Food and Drug Administration (FDA); European Medicines Agency (EMA)
Tokyo (head office)
Reimbursement price: ¥72,716,528
The company does not address Contract Value / Impact on Business Performance.
Dang et al., Neural Plast. 2017
Dams-O’Connor et al., Lancet Neurol. 2023
Internal company materials, PSP104
Internal company materials, PSP045
James et al., Lancet Neurol. 2019
Selassie et al., J Head Trauma Rehabil. 2008
Zaloshnja et al., J Head Trauma Rehabil. 2008
| Item | Details |
|---|---|
| Names of Products / Services Covered | Akugo® Intracerebral Implant Injection (generic name: vandefitemcel), Cell Therapy Telephone Consultation Hotline, Website for Healthcare Professionals |
| Offering price | Reimbursement price: ¥72,716,528 |
| Launch date | 21 May 2026 (actual date of sales launch and opening of the consultation hotline and website for healthcare professionals) |
| Applicable area | Improvement of chronic motor paralysis associated with traumatic brain injury |
| Award/certification name | Product designated under the Sakigake designation system, RMAT designation, ATMP designation |
| Awarding / certifying body | Ministry of Health, Labour and Welfare; U.S. Food and Drug Administration (FDA); European Medicines Agency (EMA) |
| Location | Tokyo (head office) |
| Quantitative Effects | Change from baseline in FMMS was 8.3±10.6 in 46 patients in the SB623 group and 2.3±4.7 in 15 patients in the sham-surgery group (24 weeks, p=0.0401) |
| Source | Dang et al., Neural Plast. 2017, Dams-O’Connor et al., Lancet Neurol. 2023, Internal company materials, PSP104, Internal company materials, PSP045, James et al., Lancet Neurol. 2019, Selassie et al., J Head Trauma Rehabil. 2008, Zaloshnja et al., J Head Trauma Rehabil. 2008 |
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.To provide patients with a new treatment option for chronic motor paralysis associated with traumatic brain injury, and to promote appropriate use and establish an environment in which patients can receive care at appropriate medical institutions.