U.S. overview
Our approved medicines have the potential to make a tangible impact on the lives of the patients we serve.
Our immediate focus, in the United States, is on advancing oncology therapeutics and care.
The product information provided below is intended for residents of the U.S. only.
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.
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:
Please Note: meeting the above expanded access criteria does not guarantee access to the applicable Servier investigational drug.
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.
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.
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.