Albireo hopes to provide access to the investigational compound odevixibat for all eligible patients to the greatest extent possible.1 To do this, we must work within the regulatory process for each country, and we must operate in a way that is sustainable, so we can supply our clinical trials, meet our ongoing commitment to trial patients, and serve the PFIC community and other rare pediatric cholestatic liver disease communities over the long term.
Albireo’s Expanded Access Program (EAP) initially will provide access to investigational compound odevixibat to eligible PFIC patients in the United States, Canada, Australia and Europe. Timing of availability in Europe will vary due to country-specific and local regulations.
Odevixibat EAP Inclusion Criteria
Based on their doctor’s assessment, patients who have had biliary diversion surgery and patients who have received a liver transplant may be eligible, as well as patients who have not had surgery.
Important Contact Information
Expanded access in other disease areas
We are not able to offer investigational drug through an expanded access program for diseases other than PFIC at this time. We will reevaluate this policy periodically, as new data become available.
For additional information about the status of our studies or for questions that you may have, contact firstname.lastname@example.org.
1 Subject to change based on Albireo’s assessment.