Sanofi’s mission is to discover and develop safe and effective innovative medicines for patients who need them. Clinical trials are a crucial component of this effort and they help to determine whether the new treatment is safe and effective. Until regulatory authorities make the final decision whether or not to approve the treatment, the treatment remains experimental and is not generally available to patients.
In certain circumstances, however, individual patients who do not qualify for these trials may ask Sanofi for access to the experimental treatment through their physician. Physicians must make the request through this link. They will receive an acknowledgment that we have received the request within 1 business day.
Criteria for Access to Experimental Product
Sanofi evaluates each request on a case-by-case basis, weighing all of the following criteria:
- Patient condition. The patient must have a serious or immediately life-threatening condition with no other treatment options available and does not qualify for an ongoing clinical trial. In the case of vaccines, the patient must be at risk of developing a serious or immediately life-threatening condition of significant public health concern.
- Potential benefit. Sanofi has a responsibility to the patient to weigh our understanding of the potential benefit of the experimental product against any risks associated with its use. Sanofi must have sufficient clinical safety and efficacy data about the product to support a favorable benefit/risk ratio for the patient.
- Supply. Sanofi must have an adequate supply of experimental product to both provide it to the patient requesting access and to support on-going clinical trials which are critical to getting the new treatment approved.
- Compliance with laws and regulations. Access to investigational product must be permitted by, and run in accordance with laws and regulations effective in the country in which the product will be administered. The physician must follow all local and national laws and regulations associated with making a request for such access.
We recognize that patients come to us when they are in need and we will treat every request carefully, fairly and quickly, respecting patient privacy.
In some cases, Sanofi may set up a program designed to provide access to a number of patients. For the US, a list of Sanofi’s expanded access/compassionate use programs can be found at ClinicalTrials.gov.
1Depending on the circumstances and the country, such access may be called Compassionate Use, Expanded Access, Early Access, Special Access or by other names.
How do you make a request?
For requests coming from all countries, please click on the link below; you should receive an acknowledgment that we have received your request within 1 business day.