Individual Access to Investigational Medicinal Products – GENFIT Policy
GENFIT is committed to developing innovative therapeutics in metabolic and liver related diseases where unmet medical needs exist, to enhance patients’ life. Wherever possible, use of an investigational medicinal product through a clinical trial is encouraged, so that patients with serious medical conditions may contribute to the generation of data to enable evaluation of products by Health Authorities.
In rare cases, when patients are unable to participate in clinical trials and have exhausted all available treatment options, GENFIT may consider providing an investigational product to individual patients outside of a clinical trial through a program called “compassionate use” or “expanded access.”
GENFIT will consider such special use outside of a clinical trial when all the following criteria are met:
- The patient has a serious or life-threatening disease;
- There is an unmet medical need or the patient has exhausted all available therapies used to treat the disease;
- The patient is not eligible or cannot participate in an ongoing or planned clinical trial;
- There is sufficient scientific evidence that the potential patient benefit justifies the potential risks of treatment;
- This compassionate use will not interfere with clinical trials or other development efforts that could support the approval of the investigational product by a health authority;
- There are sufficient clinical data about use of the investigational product to identify an appropriate dosing regimen and suitable formulation;
- There is sufficient supply to support both the ongoing clinical trials and prior approved compassionate use requests;
- All treating physicians who submit compassionate use or expanded access requests on behalf of patients must be licensed and qualified to administer the investigational medicine. The physician must comply with local laws and regulatory requirements and agree to obtain all regulatory/ethics approvals and patient informed consent; s/he is willing to conduct all necessary medical monitoring, safety reporting and data collection.
Treating physicians for patients who meet these criteria may submit requests at email@example.com.
GENFIT will acknowledge a request within 7 business days after receipt of the complete request. This request should indicate the date of request, the requesting physician contact information and a medical rationale for request including an explanation for why the patient cannot qualify for a clinical trial and why no alternative can be used.
Information about GENFIT clinical trials can be found at https://clinicaltrials.gov/ or https://www.clinicaltrialsregister.eu/ctr-search/search.
This policy is not a guarantee of access to any GENFIT investigational medicines.