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Compassionate Use / Expanded Access
Sanofi’s mission is to discover, develop and distribute safe and effective innovative medicines in areas of significant unmet medical need. To do this, we work with regulatory authorities around the world to secure timely approval of our products.
Individuals participating in our clinical trials are provided with the treatment being tested. The purpose of these trials is to discover whether the treatment is safe and effective. We submit a full complement of evidence from trials and other data to regulatory authorities, who make the final decision to approve the treatment or not. Until the regulatory authority has made this decision, the treatment remains experimental and is not generally available to patients. However, patients who are not part of these trials and meet certain criteria (see below) can request access, through their physician, to the investigational treatment. This access to investigational product is may be called Compassionate Use, Expanded access, Early Access, Special Access or by other names depending on the country from which the access is being requested.
How does Sanofi decide whether to provide an experimental treatment to a patient not in one of our trials?
We evaluate each request on a case-by-case basis, taking into account a number of considerations. We must consider the condition of the patient, their treatment options and the extent of available human safety and efficacy data on the investigational product. We have a responsibility to the patient to weigh our understanding of the potential benefit of the investigational product against the risk associated with the treatment. In deciding whether to provide the requested investigational product, we also have to consider whether doing so will compromise the supply needed for patients enrolled in ongoing clinical trials or result in delays in getting the new treatment to the broader patient population. For these reasons, we cannot guarantee that an investigational treatment will be available to a particular patient (or patients).
All the following criteria must be met for Sanofi to consider a request for access to an investigational product:
- The individual has a serious or immediately life-threatening condition or, in the case of vaccines, may be at risk of developing a serious or immediately life-threatening condition of significant public health concern, AND
- The individual does not qualify for any ongoing Sanofi clinical trials, AND
- The individual has no other viable standard of care treatment options available, AND
- All other relevant medical criteria that would allow for use of the investigational product are met, AND
- A favorable benefit/risk ratio exists for the investigational product based on the most current human clinical data, AND
- There is adequate supply of investigational product to include the use, AND
- Such use is permitted/approved based on the country, region, and /or state-specific legal and regulatory requirements in which the investigational product will be administered, AND
- The licensed treating physician has obtained an Ethical Review Board (ERB) and/or Institutional Review Board (IRB) approval, AND
- Any additional requirements set forth by law/regulation and/or institutional rules and regulations have been met.
How do you make a request?
Requests for access to investigational treatments must be made by your treating physician. We cannot accept requests directly from patients. We will treat every request with respect and dignity, and in a way that protects your privacy. We will consider each request carefully and fairly. Once we have all the necessary information, we will strive to provide our decision as quickly as we can.
For requests coming from all countries, please click on link below; you should receive an acknowledgment we have received your request within 1 business day.
For the US, in addition, a list of sanofi/genzyme/pasteur expanded access/compassionate use programs can be found at clinicaltrials.gov.
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