Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. Albireo’s lead product candidate, odevixibat, is directed to treat rare pediatric cholestatic liver diseases and is in development in its initial target indication, progressive familial intrahepatic cholestasis (PFIC). Albireo is conducting a Phase 3 trial in PFIC types 1 and 2.
The 21st Century Cures Act requires a sponsor of investigational drugs for the diagnosis, monitoring or treatment of a serious or immediately life-threatening disease or condition to publish its policy on evaluating and responding to requests for accessing those drugs outside of the clinical trial setting (“expanded access”).
Albireo is dedicated to developing odevixibat for patients and families living with the challenges of PFIC. Ensuring the integrity of our clinical trial program is critical to our efforts to secure regulatory approval and provide long-term access to as many patients as possible. For this reason, we are not able to offer investigational drug through a compassionate use program at this time. This policy will be reevaluated periodically, as new data become available.
For active clinical trials with Albireo’s investigational agents, please search “Albireo” at www.clinicaltrials.gov.
For additional information about the status of our studies or for responses to questions that you as a patient, family member or physician may have, please contact firstname.lastname@example.org. Albireo will respond to these requests within 7 days (1 week).