Bylvay® (odevixibat)

Bylvay is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure. In June 2023, Bylvay was approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome. Bylvay is also approved in the U.S. for the treatment of pruritus in patients three months of age and older with PFIC, where it has orphan exclusivity. Bylvay may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein. Bylvay was first launched as a treatment option for pruritus in patients with PFIC in the U.S. in 2021, where it is supported by a program designed to assist with access to treatment and patient support. Bylvay is also approved in the E.U. for the treatment of PFIC in patients aged six months or older. It has launched in over nine countries and has secured public reimbursement across several major markets including Germany, Italy, the U.K., France and Belgium.

Learn more about Bylvay in the U.S

IMPORTANT SAFETY INFORMATION

  • Speak with your healthcare provider if you experience abdominal pain, vomiting, diarrhea, hematoma, decreased weight, or dehydration as these have been reported with the use of Bylvay. Patients should contact their healthcare provider if they experience new onset orworsening of diarrhea
  • Elevations in liver tests (for example, AST, ALT, TB) have been observed with use of Bylvay. The patient’s healthcare provider will obtain liver tests before starting Bylvay and periodically during treatment with Bylvay. Patients should report to their healthcare provider any symptoms of liver problems (for example, nausea, vomiting, skin or the whites of eyes turn yellow, dark or brown urine, pain on the right side of the abdomen, loss of appetite)
  • Bylvay may impair absorption of fat-soluble vitamins (FSV), which include vitamins A, D, E and K (vitamin K is assessed by measuring INR). The patient’s healthcare provider will obtain serum levels of vitamins A, D, E, and INR (for vitamin K) at baseline and periodically during treatment toassess for worsening of FSV deficiency
  • Do not swallow the 200 mcg or 600 mcg capsule(s) containing Oral Pellets whole. These are intended to be opened and the contents mixed into soft food. Take Bylvay in the morning with a meal
  • For patients taking bile acid binding resins, take Bylvay at least 4 hours before or 4 hours after taking a bile acid binding resin

About Mirum Pharmaceuticals, Inc.

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology. Rare Disease and Neuroscience. With about 5,400 team members around the world, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s resech and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. For more information, visit ipsen.com.
Important Links

Information for ALGS Patients and Families: https://bylvay.com/

Non-surgical treatment for pruritus (HCPCS): https://bylvay.com/home-hcp.html

Prescribing Informaiton: https://bylvay.com/pdf/Bylvay_PI.pdf

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Applications open in early January and close in late April each year with award announcements in mid-May. Application materials will be available here each January for the academic year starting with fall term of each year.

In February 2015, the Alagille Syndrome Alliance (ALGSA) established the Alaina K Hahn Celebratory Scholarship in honor of Alaina K. Hahn, the daughter of Cindy Luxhoj, ALGSA Founder. Alaina was born September 30, 1990, with Alagille Syndrome and was the inspiration for the creation of the Alagille Syndrome Alliance. She passed away September 30, 1990, due to complications with Alagille Syndrome on January 15, 2015, when she was only 24 years old.

The Alaina K Hahn Celebratory Scholarship fund the education of high school graduates or GED credentialed recipients with Alagille Syndrome who are entering or enrolled in an accredited US university, college or vocational school and choose to pursue higher education in the human biological, medical, or health sciences field. The scholarship award is $1,000 for a single year and is renewable for a second year, subject to open competition with other applicants, for a total possible award of $2,000.

Alaina cared deeply about other children and adults who battle Alagille Syndrome. She talked, texted, and emailed her many ALGS friends daily and was constantly sharing advice and experiences with parents and patients through social media. She lived and breathed this disease, but never let it limit or define her.

A graduate in Human Physiology from the University of Oregon, Alaina was pursuing certification in Orthotics and Prosthetics with plans to obtain a Masters in O & P from the University of Washington when she died. This scholarship honors Alaina’s legacy.