Rigel Public Expanded Access Policy
Rigel Pharmaceuticals, Inc. is a biotechnology company focused on the development of novel small-molecule therapies for immunological and hematological disorders, cancer, and rare diseases. A crucial step in the development of Rigel’s investigational new drugs is to conduct clinical trials, which assess the safety and efficacy of the products. Rigel uses the data it collects from clinical trials to support marketing applications to FDA and other regulatory bodies so that Rigel can ultimately gain approval to provide access to its products on a widespread basis. Rigel has gained approval for fostamatinib to treat thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
What is expanded access?
Through expanded access, sometimes also referred to as compassionate use, patients may be able to access investigational new drugs outside of the clinical trial context. FDA will typically facilitate expanded access to investigational products for patients with serious or life-threatening conditions when there is a lack of adequate therapeutic alternatives. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety and effectiveness.
What is Rigel’s policy on expanded access?
Rigel believes the best way to access our investigational products is through participation in one of our ongoing clinical trials. We believe that access to investigational therapies should be limited to controlled clinical trials until such time as the safety, tolerability and effectiveness of a therapy has been determined and confirmed by regulatory authorities. Pre-approval access outside of a controlled clinical trial may interfere with the conduct of our ongoing trials and may also disrupt the progress of our development programs, which would, in turn, delay access to many other patients in need.
For all of the foregoing reasons, Rigel has reached the difficult decision to not accept expanded access requests at this time. This policy is subject to change at the discretion of Rigel and this webpage will be updated should there be a change.
How can I get more information?
For more information on clinical trials, see https://clinicaltrials.gov. Search “Rigel” to find Rigel clinical trials that may currently be recruiting. If you are a healthcare professional and would like more information on Rigel’s investigational products, please send an inquiry to firstname.lastname@example.org.