Sponsor Overview
Explore verified public information about Sanofi's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 3 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 5 supporting sources.
“MAPs are programs under which investigational medicines or medicines for which a marketing authorization application is ongoing may be used to treat certain patients who cannot enroll in an ongoing clinical trial. Sanofi “Managed Access” addresses the need of treating patients affected by life-threatening or seriously debilitating illnesses by making such medicines available to eligible patients.”
“Healthcare professionals (HCPs), healthcare institutions (HCIs), and Health Authorities in some countries may request earlier access to treatments for their patients by requesting a Pre-Registration Import License (PRIL) from Sanofi.”
“Sanofi’s mission is to discover and develop safe and effective innovative medicines and vaccines 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 formal request to Sanofi on behalf of the patient. 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. A list of Sanofi’s expanded access/compassionate use programs for the US can be found at ClinicalTrials.gov.”
“Les Programmes d’Accès Géré (« Managed Access Program » ou MAP) sont des programmes sous lesquels des médicaments expérimentaux ou non-autorisés et/ou pour lesquels une demande d'autorisation de mise sur le marché est en cours, peuvent être utilisés pour traiter certains patients non éligibles à l’inclusion dans un essai clinique en cours. Sanofi « Managed Access » répond à la nécessité de traiter avec ces médicaments certains patients éligibles atteints d’une maladie ou affection potentiellement mortelle ou gravement débilitante.”
“Sanofi will consider providing our clinical trial patients with access post-trial.”
Past EAPs on ClinicalTrials.gov
Score contribution: 40 — 6 supporting sources.
Conditions: Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
Conditions: Glycogen Storage Disease Type II (GSD-II), Pompe Disease (Late-Onset), Acid Maltase Deficiency Disease, Glycogenosis 2
Conditions: Autologous Stem Cell Transplant
Conditions: Glycogen Storage Disease Type II, Glycogenosis 2
Conditions: Breast Cancer
Conditions: Sphingomyelin Lipidosis
Reagan-Udall Foundation Insights
Partner with Right2Hope
Right2Hope helps sponsors translate regulatory programs into actionable patient access pathways. Connect with our team to publish new programs, streamline intake workflows, or align with providers seeking compassionate use options.