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Pharma Tech Outlook | Wednesday, September 29, 2021
Bylvay, the first drug used for every type of progressive familial intrahepatic cholestasis (PFIC), is now available by prescription to patients in Germany,
FREMONT, CA: Bylvay (odevixibat), the first drug approved in Europe to diagnose every type of progressive familial intrahepatic cholestasis (PFIC), is now available by prescription to patients in Germany, says Albireo Pharma, Inc., a rare pediatric liver disease company developing novel bile acid modulators. In the United States, Bylvay is also approved for the treatment of pruritus in every kind of PFIC. Bylvay is a non-systemic ileal bile acid transport inhibitor (IBATi) that can be taken once a day as a capsule or opened and sprinkled on soft meals, and it does not need to be refrigerated.
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"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, the University of Tubingen 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 currently available at pharmacies around the country. Albireo's sales drive has already started, with commercial employees visiting major centers to advise them of Bylvay's availability for the treatment of PFIC and the patient care services offered. Once Bylvay has been prescribed, healthcare practitioners and families will have the option of using Albireo Assist, a personalized patient support program developed with input from medical experts and patient advocates to help patients and caregivers along 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."
"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.
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