Expanded Access Policy
Aimmune is a biopharmaceutical company developing therapies for the treatment of food allergies. 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 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.
Aimmune believes the best way to access its investigational products is through one of its controlled clinical trials. At this time, Aimmune is not able to grant requests for expanded access to its investigational therapies.
Clinical Trials: For more information on Aimmune clinical trials that may be recruiting, search “Aimmune” at www.clinicaltrials.gov.
Contact Information: A treating physician may request additional information about Aimmune’s clinical trials via email at the following address: email@example.com.
The posting of this policy by Aimmune shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
Aimmune may revise this expanded access policy at any time. This posting will be updated should there be any policy change.