How We Evaluate Requests
If early data from clinical trials support the potential benefit of an investigational drug for a serious disease, Servier will consider requests to provide expanded access outside of a clinical trial. Expanded access requests submitted to Servier will be considered on a case-by-case basis and evaluated based on criteria including, but not limited to:
- The patient must have an immediately life-threatening condition or serious disease, have exhausted the standard of care and/or all available therapies typically used to treat the disease, and be ineligible for any relevant clinical trials.
- The requesting physician must be appropriately qualified and licensed with expertise and facilities suitable for administering the investigational drug and for managing the patient and reporting side effects.
- Sufficient efficacy and safety data must exist to enable Servier to determine whether the potential benefit to the patient outweighs the collective potential risks to the patient.
- Supplies of investigational drug are often limited and Servier must be able to provide it in an equitable manner and ensure it can maintain an adequate supply of the investigational drug without impairing the timely completion of clinical trials or ongoing drug development that could lead to broader patient availability.
- The access must be permitted under applicable laws and regulations.
Please Note: meeting the above expanded access criteria does not guarantee access to the applicable Servier investigational drug.