Rigel Pharmaceuticals, Inc. is a biotechnology company focused on the development of novel small-molecule therapies for hematological disorders and cancer. A crucial step in Rigel's development of investigational new drugs is to conduct clinical trials, which assess safety and efficacy. Rigel uses the data it collects from clinical trials to support marketing applications to the FDA and other regulatory bodies to gain approval to provide access to its products on a widespread basis.
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 access to investigational products outside clinical trials, including 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 the reasons described above, Rigel does not offer expanded access programs in the United States at this time. However, in limited circumstances, patients who have participated in a clinical trial involving the product may be eligible for post-trial continued access on a case-by-case basis, where appropriate and permitted by applicable laws and regulations.
Outside the United States, Rigel may make products available through expanded access or similar access mechanisms, subject to local laws, regulations, and program requirements.
Outside the United States, Rigel currently provides access to olutasidenib (Rezlidhia®) in France through the Autorisation D’Acces Compassionel (AAC) program. The AAC program is managed by WEP Clinical LTD. Physicians seeking additional information about access to olutasidenib through the AAC program may contact: aac-olutasidenib@wepclinical.com.
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 producthelp@rigel.com.