Benzinga | Sep 15, 2021 08:34AM EDT

Albireo Announces Bylvay (odevixibat) Now Available In Germany

Albireo Pharma, Inc. (NASDAQ:ALBO), a rare pediatric liver disease company developing novel bile acid modulators, today announced that Bylvay (odevixibat), the first drug approved in Europe for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC), is now available by prescription to patients in Germany. Bylvay is also approved in the U.S. for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay is administered as a once-daily capsule or opened and sprinkled onto soft foods and does not require refrigeration.

"With the availability of Bylvay in Germany, we are now able to offer the first non-surgical treatment option to the PFIC patients who are experiencing difficult developmental and physical symptoms," said Ekkehard Sturm, M.D., Ph.D., Pediatric Hepatologist and Head of Pediatric Gastroenterology-Hepatology, Liver and Intestinal Transplantation at Children's Hospital, University of T?ebingen in Germany. "We are hopeful that Bylvay will help patients avoid complications associated with surgery and provide them with much needed relief from their symptoms."

Bylvay is now available through retail pharmacies. Sales promotion has already begun, with Albireo commercial staff covering the key centers to inform them of the availability of Bylvay for the treatment of PFIC and the patient support services available. Once Bylvay is prescribed, healthcare providers and families will have the option to use Albireo Assist(r), which is a customized patient support program built with input from medical experts and patient advocates that aims to support patients and caregivers throughout their treatment journey.

"We are excited to bring the first drug treatment option to PFIC patients in Germany, which has the largest market potential in Europe," said Pamela Stephenson, Chief Commercial Officer of Albireo. "We have an experienced German team, including, commercial, medical and operations who are on the ground running. Based on our initial conversations with healthcare providers, we know that there is great interest in Bylvay and we are confident in the uptake."

To support payor decision-making, Albireo has submitted a value dossier to the Joint Federal Committee (G-BA) in Germany with the PEDFIC 1 and PEDFIC 2 Phase 3 data, including long-term data with patients on drug for over two years; natural history information; and a caregiver study to reflect the burden of PFIC. This submission commences the drug benefit assessment process. General national reimbursement will be granted throughout the entire process as well as thereafter.

"The PFIC patients around the world who are experiencing extreme challenges and diminished quality of life underscore our urgency to continue on our path towards global availability," said Ron Cooper, President and CEO of Albireo.

Albireo has launched Bylvay in the U.S. and is working to commercialize Bylvay in other European countries. Bylvay is currently being evaluated by a number of reimbursement agencies in Europe. Albireo is working closely with all relevant agencies to ensure access for patients in Europe as quickly as possible. Outside the U.S., access to Bylvay is available through our Managed Access Program. For more information on this program, please visit https://www.albireopharma.com/patients-families/patient-access.

Bylvay is currently being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, ASSERT Phase 3 study for Alagille syndrome and in the BOLD Phase 3 study for patients with biliary atresia. The ASSERT and BOLD studies remain on track to report topline data in 2022 and 2024 respectively.