Expanded Access Policy Statement
Clinical development is a critical part of evaluating experimental therapies as potential impactful medicines for people with rare cholestatic liver diseases. We are committed to rigorous testing of experimental treatments with the goal of securing regulatory approval and enabling the medicine to be available to as many patients as quickly as possible.
Expanded Access Program for Alagille syndrome
Mirum’s Expanded Access Program (EAP) for Alagille syndrome (ALGS) is now open in the United States and Canada, offering access to maralixibat for the treatment of cholestatic pruritus in eligible patients with ALGS who do not have access to ongoing clinical trials.
Requests to participate in this program must be made by a licensed physician. Physicians and patients can learn more about the maralixibat EAP for ALGS by visiting the program website at www.ALGSEAP.com or clinicaltrials.gov/ct2/show/NCT04530994 or contact MirumALGS@clinigengroup.com.
Unfortunately, we are not able to offer expanded access to our investigational treatments in diseases other than ALGS, or in regions outside of the US and Canada, at this time. We will periodically reevaluate this policy as new data become available.
To learn more about Mirum’s open clinical trials, please visit Clinical Trials at Mirum, pfictrial.com or clinicaltrials.gov.