Astellas is committed to making our medicines available to patients in the most efficient manner to address their unmet medical needs. The general approach is through the conduct of clinical trials and subsequent registration and commercialization of our products. However, Astellas recognizes that patients with serious or life-threatening diseases may have exhausted all of their available treatment options, may not qualify for a clinical trial and may seek access to investigational medicines.
Our Expanded Access to Investigational Position outlines how to request access to such medicines, and criteria for potential eligibility. Below are those instructions for both HCPs and Patients on how to make a request. Valuable resources for understanding the EA process are included here to help, please find them on this page as well.
Healthcare Professional Requests
If you are a Healthcare Professional and would like to make a request for compassionate use of an Astellas investigational medicine, please email the Astellas Expanded Access at [email protected] or call 800-727-7003.
Please include the following information when reaching out.
- The project code or compound name
- Name and contact number of a patient’s physician
- No information which may identify patient
Physicians outside the US should contact their local Astellas office, visit https://www.astellas.com/worldwide/ for a directory.
If you are a patient and would like to make a request for compassionate use of an Astellas investigational medicine, please contact your Healthcare Professional.
Expanded Access Navigator
The Expanded Access Navigator (EA Navigator) provides a roadmap to guide patients, caregivers and physicians regarding the EA process. The EA Navigator represents a unique partnership between the Regan-Udall Foundation for the FDA, patient advocacy organization, the pharmaceutical industry, and the federal government to provide clear, digestible information on single-patient EA. It contains resources including a list of specific therapies available for single-patient expanded access, links to clinicaltrials.gov record numbers, as well as links to disease or condition-specific expanded access policies.
The FDA Expanded Access Page contains information for Patients and Physicians, as well as general background on EA:
- Patients: Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more
- Physicians: Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more.