Provision of Unapproved drugs mainly from a humanitarian perspective
When access to certain drugs that are investigational, unapproved or approved but not yet marketed (hereinafter referred to as "Unapproved drugs") for diseases for which no other treatment is available is extremely limited, Nippon Shinyaku will consider implementing a program to provide such drugs from a humanitarian perspective, provided that clinical trials are underway that enable Nippon Shinyaku to accumulate safety information or that the drug is already approved in certain regions. Currently, Nippon Shinyaku has the following programs as such initiatives. We will support the provision of Unapproved drugs in the future, if such programs can be implemented in accordance with the regulations of each country, taking the following points into consideration.
- ・The disease must be serious or life-threatening, and there must be no other treatment available that has an equivalent or sufficient therapeutic effect.
- ・If a clinical trial is underway but the patient is unable to participate in it.
- ・The development of the drug has not been terminated, and we are in a position to appropriately collect information on the safety and efficacy of the drug.
- ・Based on the available clinical data, it is supported from ethical and scientific perspectives that the benefits of providing the Unapproved drugs outweigh the risks.
- ・If a clinical trial is underway, the provision of the drug will not adversely affect or delay the clinical trial.
- ・The drug can be provided in sufficient quantities.
Currently ongoing Unapproved drugs donation programs
Viltepso - EAP (expanded access program): A free-of-charge donation program in the form of an expanded clinical trial for patients participating in current clinical trials, where the patient and physician request continued administration from a humanitarian standpoint after the trial is completed.
Viltepso - NPP (named patient program): A fee-based program for patients in unapproved regions and/or where access to clinical trials is not possible, where patients and physicians request the drug from a humanitarian perspective, and where the Nippon Shinyaku’s criteria for safe drug use are met.
