Expanded Access Policy
Attralus is focused on the discovery and development of transformational products to improve the lives of patients with systemic amyloidosis.
Expanded access refers to the use of an investigational therapy or diagnostic agent outside of a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient rather than to obtain the kind of information about the drug that is generally derived from clinical trials. We understand the need and recognize the importance of Expanded Access programs. More information about Expanded Access can be found on the Food & Drug Adminstration (FDA) Expanded Access website.
At this time, participation in one of our Attralus clinical trials or investigator-sponsored clinical trials is the only way to access any Attralus investigational products. For more information regarding clinical trials with Attralus investigational therapies or diagnostics, please visit www.clinicaltrials.gov.
Expanded access requests will be referred to study investigators to determine whether a patient is eligible for any ongoing clinical trials. If a patient does not qualify for one of our ongoing clinical trials, referrals may also be provided to patient organizations and/or academic centers who may be able to identify other appropriate clinical trials or approved treatment options.
If you have questions, please speak with your physician or contact Attralus directly at medicalaffairs@attralus.com. Attralus will acknowledge receipt of requests sent to this email within seven business days. In line with the FDA’s 21st Century Cures Act, Attralus may revise this website and programs at any time.