Expanded access in progressive familial intrahepatic cholestasis (PFIC)

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

  • Clinical confirmation of any form of PFIC (no genetic confirmation required)
  • Episodic forms of PFIC (i.e., BRIC) are allowed
  • Elevated serum bile acids
  • Pruritus (requirement in U.S. only)
  • No other therapeutic options available
  • No access to current clinical trials

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

  • If you are a physician in the U.S. and Canada who would like to request EAP access for your patient, contact Odevixibat@clinigengroup.com.
  • If you are a physician in Australia or Europe who would like to request EAP access for your patient, contact medicineaccess@clinigengroup.com.
  • If you are someone with PFIC or the caregiver of someone with PFIC in the U.S., Canada, Australia or Europe, and you would like to request EAP access, share this contact information with your doctor. Your doctor will determine whether you are a good candidate for the program and, if so, request access.
  • We will acknowledge receipt of requests for EAP access within 5 days of receipt.
  • Our aim is to expand this program to other geographies over time. If you are a physician, patient or caregiver of a patient outside of the U.S., Canada, Australia or Europe who may be interested in EAP access, email medinfo@albireopharma.com with your interest.

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 active clinical trials with Albireo’s investigational agents, including odevixibat, please search “Albireo” at www.clinicaltrials.gov.

For additional information about the status of our studies or for questions that you may have, contact medinfo@albireopharma.com.

1 Subject to change based on Albireo’s assessment.