Our medications are changing the lives of the patients we serve. Currently, within the United States, oncology treatment and care are our immediate focus. We have four medicines available in multiple indications:
Globally we have a broad portfolio of medicines which are prescribed in almost 150 countries. The availability, name and indicated use of our medicines may vary globally. Each country has different drug approval processes for the specific purpose of the medication; please consult local regulators for more information. To learn more about which Servier products are available in your country visit Our Servier Medicines.
Expanded Access Policy
Servier is committed to providing innovative therapeutic solutions to treat and care for patients. Patients who meet certain defined criteria may be eligible to participate in Servier’s clinical trials to access investigational drugs before the drugs have been approved for a current commercial use in the patient’s disease. Servier recognizes that patients and their physicians may believe that a patient with a serious or immediately life-threatening disease could benefit from Servier’s investigational drugs, even if the patient does not qualify for participation in one of Servier’s clinical trials.
An Expanded Access Program, also known as “compassionate use,” is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials.
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.
How to Submit a Request
Patients interested in seeking expanded access to a Servier investigational drug should talk to their physician. Requests on behalf of a patient can only be considered when initiated by a licensed physician qualified to administer and oversee the investigational treatment and comply with safety requirements, including safety reporting responsibilities.
- Any requests for expanded access must be initiated and submitted to Servier through a patient’s treating physician at the following email address: ExpandedAccess@servier.com.
- The requesting physician must be willing to obtain approval from the relevant Institutional Review Board, obtain an Investigational New Drug Application (IND) from FDA, if necessary, and otherwise comply with federal, state, and local regulations.
- The request must include contact information for the treating physician and sufficient supporting documentation to allow Servier to evaluate the request.
Response Time and Additional Information
Servier will make best efforts to acknowledge and/or respond to expanded access requests within three business days and, after all relevant information has been received, provide a final decision within 5 -10 business days.
For more information about US expanded access programs, please visit www.clinicaltrials.gov.
For additional information on Expanded Access, patients, caregivers and patient advocates may visit the U.S. Food and Drug Administration website: Expanded Access: Information for patients.
Physicians may find additional information on Expanded Access by visiting the U.S. Food and Drug Administration Website Expanded Access: Information for Physicians.
Our Focus on Value
The patients we serve are our top priority. We are committed to providing the best value for their care. We work to establish a medicine's price that reflects the value it offers to patients and the healthcare system, based on a range of factors including impact on patients and their disease relative to other available treatments and the potential to reduce additional health care costs, such as hospital stays. We remain committed to ensuring our treatments offer real value as determined by our patients' outcomes, choices and advanced care.
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