Announced details
Treatment of mucopolysaccharidosis types I and II, lysosomal diseases, neurodegenerative diseases, and central nervous system symptoms
JR-171 received Fast Track designation from the U.S. Food and Drug Administration (FDA).
U.S. Food and Drug Administration (FDA)
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
U.S. Food and Drug Administration (FDA), References 1–8, and Company research
| Item | Details |
|---|---|
| Names of Products / Services Covered | JR-171（lepunafusp alfa）, JR-141（pabinafusp alfa）, J-Brain Cargo®, IZCARGO® intravenous infusion 10 mg |
| Launch date | IZCARGO® 10 mg for intravenous infusion, the JR-141 product, has been marketed since May 2021. |
| Applicable area | Treatment of mucopolysaccharidosis types I and II, lysosomal diseases, neurodegenerative diseases, and central nervous system symptoms |
| Award/certification name | JR-171 received Fast Track designation from the U.S. Food and Drug Administration (FDA). |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
| Source | U.S. Food and Drug Administration (FDA), References 1–8, and Company research |
Items this document does not state (12)
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 promote advances in research and medical care relating to mucopolysaccharidoses and related lysosomal diseases, and to demonstrate the potential of the J-Brain Cargo® technology in the treatment of lysosomal diseases and neurodegenerative diseases.