In our commitment to ensuring that eligible patients can access Bylvay™ (odevixibat) to the greatest extent possible in a fully compliant manner, we have implemented a Managed Access program for patients outside the U.S.
As reimbursement is granted in countries outside the U.S., the intent is for patients with PFIC to access Bylvay through their healthcare providers (HCPs). However, country-level timings for reimbursement typically vary significantly depending on local processes so individual patient access to Bylvay in certain countries outside of the U.S. will now be available through our Managed Access Program, as well as the ongoing PEDFIC 2 clinical study.
Please see below for who to contact for information regarding individual access via our Managed Access Program or clinical trials.
We are not able to offer investigational drugs through our Managed 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, please contact email@example.com.
Due to recent marketing authorization and commercial availability, our Expanded Access Program (EAP) is closed to new patient enrollments. Patients currently accessing Bylvay via the EAP, or clinical trial, will continue to receive treatment.