EXPANDED ACCESS
POLICY

Aimmune is a biopharmaceutical company on a mission to transform the lives of patients and their families by developing pharmaceutical therapies to prevent, manage, and treat food, gastrointestinal (GI), and metabolic-related diseases. As a part of the drug development process, Aimmune conducts human clinical trials to show that its investigational products are safe and effective. The data from these trials are used to support marketing applications submitted to the U.S. Food and Drug Administration (FDA) and other regulatory authorities.

Under FDA regulations, expanded access to investigational new drugs may be made available to certain patients outside of the clinical trial setting. FDA permits the manufacturer of an investigational drug for the diagnosis, monitoring, or treatment of a serious or immediately life-threatening disease or condition to provide individual patients with access to the investigational drug, outside the setting of a clinical trial, if certain criteria are met. A manufacturer developing drugs for serious or life-threatening diseases or conditions that has advanced to a certain stage of development must make its policy on evaluating and responding to requests for such “expanded access” publicly and readily available.